Description

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.

We’re looking for a Senior CRA to join our Functional Services team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.

At Premier Research, we are science-minded and heart-centered. Join us.

This is a Senior CRA position within our sponsor-embedded team. We are seeking a Senior CRA in the Florida region who has Spanish reading/speaking fluency. 

What you'll be doing:

Role: Site Manager

• Ensures monitoring, monitoring report review/finalization, event reporting and all other monitoring commitments are performed in accordance with the study monitoring plan.
• Manages assigned clinical sites, partnering with field monitors and site staff to iden­tify and escalate or resolve compliance issues, and escalation of site questions or needs.

Role: Monitor

• Conducts qualifications, initiation, interim and close out visits. Ensures all appropriate site staff are trained, have access to required electronic systems, and are informed of data collection, GCP, protocol and reporting requirements.
• Participates as an extended team member of the clinical study team including participating in study-specific meetings, teleconferences, and investigator meetings.

Role: Quality and Process Improvement Champion

• Identifies and ensures communication of the need for corrective action at clinical sites. Collaborates with colleagues and clinical sites to develop and execute correc­tive action plans.
• Identifies process improvement opportunities. Independently proposes solutions/plans.

What we are searching for:

• Bachelor’s Degree or equivalent experience required
• Must have at least 5+ years of practical experience conducting continuous independent onsite monitoring of clinical research sites and site management activities.
• Must be able to travel up to 75%
• Must be able to read/speak Spanish

Why choose Premier Research?

• Premier Research is more than a company –it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need
• Our cultural anchors –Caring & Empathy, Empowerment, Aspiration, One Team –mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.  

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others. 

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, or veteran status. 

Description

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today. 

We’re looking for a Project Manager II/ Senior Project Manager to join our Analgesia Project Delivery team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success. 

What you’ll be doing:  

• Ensures successful management and coordination of efforts assigned to all members of the project team, including but not limited to Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety, to support milestone achievement and overall project delivery 
• Maintains and evaluates study progress by using company tracking systems, project timelines and budget reviews and projecting profitability  
• Manages the project team to ensure study progress is according to both client and Premier Research requirements and in compliance with standard Premier Research processes, policies and procedures 
• Ensures effective communication is maintained and project status reports and monthly progress reports are provided both internally and externally 
• Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training 
• Prepares forecasts for staff utilization over the life of the study and ensures adequate resourcing is available to meet project deliverables and milestones 

What we are searching for in a Project Manager II:   

• Bachelor’s degree preferably in a clinical, biological or science-related field from an accredited college or university, or equivalent combination of education and experience 
• 6 years of clinical research experience
• 3 years of project management experience, preferably with a CRO

What we are searching for in a Senior Project Manager:   

• Bachelor’s degree preferably in a clinical, biological or science-related field from an accredited college or university, or equivalent combination of education and experience 
• 8 years of clinical research experience
• 5 years of project management experience, preferably with a CRO
• Experience working globally

Why choose Premier? 

• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and most importantly about our mission of furthering research to improve the lives of patients in critical need.
• Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

At Premier Research, our mission is to improve healthcare by transforming life-changing ideas into new medical treatments that address the unmet needs of a diverse global population. Achieving this is impossible without creating a culture where our employees are given the power to think creatively, challenge ideas, and solve complex problems fearlessly.

Through a commitment to diversity, equity, inclusion, and empowerment, we strive to create a community of belongingness where our differences are welcomed and celebrated. It fuels our innovation and better connects us to the patients, physicians, and customers we serve.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status. 

Description

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.

We’re looking for a Senior CRA to join our Functional Services team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.

At Premier Research, we are science-minded and heart-centered. Join us.

This is a Senior CRA position within our sponsor-embedded team. We are seeking a Senior CRA in the Florida region. 

What you'll be doing:

Role: Site Manager

• Ensures monitoring, monitoring report review/finalization, event reporting and all other monitoring commitments are performed in accordance with the study monitoring plan.
• Manages assigned clinical sites, partnering with field monitors and site staff to iden­tify and escalate or resolve compliance issues, and escalation of site questions or needs.

Role: Monitor

• Conducts qualifications, initiation, interim and close out visits. Ensures all appropriate site staff are trained, have access to required electronic systems, and are informed of data collection, GCP, protocol and reporting requirements.
• Participates as an extended team member of the clinical study team including participating in study-specific meetings, teleconferences, and investigator meetings.

Role: Quality and Process Improvement Champion

• Identifies and ensures communication of the need for corrective action at clinical sites. Collaborates with colleagues and clinical sites to develop and execute correc­tive action plans.
• Identifies process improvement opportunities. Independently proposes solutions/plans.

What we are searching for:

• Bachelor’s Degree or equivalent experience required
• Must have at least 5+ years of practical experience conducting continuous independent onsite monitoring of clinical research sites and site management activities.
• Must be able to travel up to 75%

Why choose Premier Research?

• Premier Research is more than a company –it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need
• Our cultural anchors –Caring & Empathy, Empowerment, Aspiration, One Team –mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.  

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others. 

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, or veteran status. 

Description

· Assists with Quality Control (QC) of specified deliverables

· Creates electronic Case Report Forms (eCRFs) according to finalized protocols for

EDC studies

· Creates data entry screens according to the approved annotated Case Report Form

(CRF) for paper studies

· Participates in database building design and testing according to Premier Research

standard operating procedures in operation at that time

· Assists in programming field derivations, edit/consistency checks, and setup of

screen flow in the CDMS for Data Entry

· Assists in writing procedures, validation and data extraction programs

· Produce database documentation including an annotated CRF.

· Ensure database documentation is maintained for the Trial Master File

· Works in collaboration with the Data Management project team, Statistician, Project

Manager and the sponsor to define all technical elements of the Data Management

plan

· May assist in maintaining the CDMS global and program libraries

· All other projects as assigned

Description

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

We’re looking for an exceptional Site Payment Specialist to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.  

This position has working hours of 11am-7pm or 12pm-8pm local time in Slovakia.

At Premier Research, we are science-minded and heart-centered. Join us.

This position can be remote-based but if possible, we welcome a hybrid in-office and remote model. 

What you'll be doing:

• Reviews and interprets payment terms as outlined in global clinical site payment documents for each contract executed (e.g., North America and Rest of World (ROW) Clinical Trial Agreements (CTAs), budget grids, amendments, change orders and budget modification letters)
• Ensures the payment configuration requirements are clearly delineated and defined for each study (backup requirements, manual vs. Electronic Data Capture (EDC) driven, bulk vs. individual line items, etc.) 
• Escalates ambiguous payment information to contract negotiator for clarification 
• Extracts payment information (e.g., amounts, caps, limits, backup requirements) from clinical site payment documents and populates machine readable payment system template to facilitate site set up in the payment system
• Distinguishes between data driven and manual payment line items and configure accordingly 
• Reviews site setup in the payment system to ensure there are no errors 
• Collaborates and communicates with business partners  
• Ensures finance activities are completed within timelines as per service level agreements 
• Troubleshoots issues and ensures problems are seen to resolution 
• Performs additional duties as assigned

What you'll need:

• 2-4 years of practical experience in global site finance activities and/or clinical trial finance including hands-on experience writing, interpreting, or reviewing payment terms in global Clinical Trial Agreements (CTAs). Alternately, must have proven experience in all primary job functions
• Demonstrates excellent English verbal and written communication skills
• Excellent computer skills in a Microsoft Windows environment including proficiency in the Microsoft Office Suite of tools (eg - Outlook, Work, Excel, etc)
• Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership
• Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities
• Proven ability to mentor others by instructing and developing capabilities

Why choose Premier Research?  

• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need. 
• Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve. 

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

#LI-KT1

Description

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.

We’re looking for a Associate Director Biostatistics join our Biostatistics team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.

What you’ll be doing: 

• Participates and contributes to the training and development of new biostatisticians
• Supervises, mentors, and motivates reporting associates in tasks and activities in order to develop the team structure
• Peer reviews draft statistical analysis plans and provides feedback
• Acts as Lead Biostatistician to interact with the study team and the sponsor
• Independently develops statistical analysis plans
• Performs QC of TLFs, CDISC and other analysis data sets
• Prepares specifications for CDISC and other analysis data sets
• Presents biostatistical capabilities in bid defense meetings
• Acts as an independent biostatistician on DSMBs and DMCs
• Acts as project manager for biostatistics stand-alone work
• Independently develops SAS programs to generate randomization codes

• Strategic responsibility for all staffing and operational aspects of the allocated Biostatistics group
• Supervises SAS programming and program validation for a project
• Leads efforts in the development, maintenance and adherence to departmental SOPs and guidelines
• Develops and implements strategies to actualize goals
• Ability to lead process improvement efforts
• Keep detailed records of time spent on each project to allow accurate billing
• Maintain biostatistical section of TMF
• Ability to manage and de-escalate difficult situations with clients, teams, and management
• Ability to motivate and lead a team of varying levels of status and ability
• Attend project team meetings as required
• Capability and willingness to coach and mentor others
• Demonstrated critical thinking with a history of bringing forward strategic initiatives
• Develop and maintain overall awareness in the field of biostatistics by reading related literature, attending training classes, professional meetings, statistical conferences etc.
• Supports Business Development concerning budget and proposal development
• Directs efforts in Biostatistics project costing estimates and change order process
• Ensures that audits have appropriate Biostatistics representation
• Perform other work-related duties as assigned
• Provides consultancy to sponsors on statistical issues
• Provides oversight and reporting of project progress and financial health within Biostatistics
• Provides statistical input to Clinical Trial Reports
• Respect and maintain the confidentiality of the processed material and ensure that any regulations concerning security or confidentiality (such as the safeguarding of passwords) are complied with
• Review data management documents
• Supports Business Development by preparing for and attending bid defense meetings
• Tracks hours worked on projects and forecasts hours to complete
• Tracks project revenue and backlog

What we are searching for:  

• Previous experience in clinical trials design and analysis using SAS
• Previous experience as supervisor/manager
• Prior experience using computerized information systems preferred.
• Ability to read, write, and speak fluent English; fluent in host country language.
• Knowledge of ICH and local regulatory authority drug research and development regulations preferred.
• Works with internal and external customers/vendors to meet project specific goals.
• Identifies, monitors, documents, and tracks out-of-scope activities.
• Demonstrated experience in interactions with regulatory agencies (e.g., FDA, EMA, EU member states, etc.)
• Fluent verbal, written, and interpersonal English as well as the local language(s) required for clinical trial submissions.
• Excellent team player, collaborative and able to build an effective team.
• Ability to multitask and work effectively in a fast-paced environment with changing priorities.
• Strong verbal and written communication and negotiation skills.
• Excellent organizational and time-management skills, able prioritize work to meet deadlines.
• Accountable, dependable and strong commitment

Why choose Premier Research?  

• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need. 
• Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, or veteran status.

 #LI-KT1

Description

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.

We’re looking for a Associate Principal Biostatistical Programmer join our Biostatistics team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.

What you will be doing:

Develops and tests SAS Software programs to complete complex Biostatistical analyses identified in statistical analysis plans with no supervision.

· Develops, tests, and validates complex Tables Listings, and Graphs for specific projects and project shells in the Global Biostatistics Department.

· Develops and tests SAS Software programs to complete quality control and validation work on SAS Software programs generated by other Biostatistical programmers as part of the SOP.

· Develops and tests SAS Software programs using SAS to manipulate and/or import external data into Analysis SAS data sets or export SAS output to other computer files for delivery to clients.

· Develops SAS Software programs to create derived, complex, Biostatistical parameters and output, derived data sets (e.g., adverse events with multiple merging and cleaning procedures), or other required advanced data manipulation to support completion of Biostatistics projects.

· Provide primary Biostatistical programming support for integrated summaries of safety and efficacy (ISS and ISE) supporting regulatory submissions that Premier Research is completing.

· Lead programming tasks using software other than SAS to support Biometrics or specialized data analysis requirements, as assigned.

· Prepares documents to describe SAS Software programs as assigned.

· Train junior level Biostatistical programmers, Biostatisticians, and management on advanced SAS software programming techniques and efficiencies to improve productivity in the Global Biostatistics Department.

· Performs group and departmental Quality Control (QC) procedures

· All other projects, and learning activities, as assigned

What we are searching for:

· BS or equivalent from accredited college or university, in statistics, IT, mathematics or closely related field or work related experience to be able to perform this role

· 4-6 years of experience in SAS programming within the area of clinical trials.

· Prior experience using computerized information systems preferred.

· Knowledge of ICH and local regulatory authority drug research and development regulations preferred.

· Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook

· Demonstrated working knowledge of data processing, database design and organization in clinical data environment

· Demonstrated working knowledge of basic clinical trial design and analysis principles

· Working knowledge of CDISC standards and application of these standards to projects

· Working knowledge and understanding of advanced statistical concepts to program analysis datasets and tables which include descriptive and standard/complex inferential statistics

· Fluent verbal and written English as well as the local language(s) required for clinical trial submissions.

· Excellent team player, collaborative and able to build an effective team.

· Ability to multitask and work effectively in a fast-paced environment with changing priorities.

· Strong verbal and written communication and negotiation skills.

· Excellent organizational and time-management skills, able prioritize work to meet deadlines.

· Accountable, dependable and strong commitment.

· Is customer service focused in approach to work both internally and externally.

· Maintains a positive, results orientated work environment.

· Ability to build client confidence and achieving high levels of customer satisfaction

· Attention to detail and ability to independently work on stand-alone Biostatistical projects with general supervision

Why choose Premier Research?  

• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need. 
• Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, or veteran status.

#LI-KT1

Description

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today. 

Clinical research takes time and with patients desperate for answers, we are doing everything we can to deliver studies on time. That’s why our Project Managers are so essential. We are looking for a Project Manager to join our Dermatology team to help ensure that critically ill patients around the world are able to get the treatment options they’ve been waiting for. As a PM at Premier Research, you’ll provide a patient centric, customer-focused leadership to achieve on-time, on-budget high-quality project results in a supportive and flexible work environment.

You'll be accountable for:

• Successful management and coordination of efforts assigned to all members of the project team, including but not limited to Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety, to support milestone achievement and overall project delivery
• Adherence to project budget and scope of work to realize project profitability
• All project tasks completion in accordance with project plans and in compliance with global and consistent Premier Research processes, policies, and procedures
• Effective communication, and project status reports and monthly progress reports are provided both internally and externally

As a PM II you will need to be creative, delivery focused, and require:

• Bachelor’s degree preferably in a clinical, biological or science-related field from an accredited college or university, or equivalent combination of education and experience
• 6 years relevant experience, preferably in a CRO/pharmaceutical company/medical device company, including 2 years of clinical project management or clinical management experience
• 3 years of experience in managing progressively large and complex scientific research projects, at least half of which has been in a matrix environment and strong budget/finance experience 
• Demonstrated understanding of therapeutic and protocol disciplines in Dermatology, ICH/GCP regulations, FDA guidance documents/EU directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures

As a SPM you will need to be creative, delivery focused, and require:

• Bachelor’s degree preferably in a clinical, biological or science-related field from an accredited college or university, or equivalent combination of education and experience
• Minimum 8 years relevant experience, preferably in a CRO/pharmaceutical company/medical device company, at least half of which has been in a matrix environment
• 5 years of experience serving as a Project Manager for complex and/or international clinical trials and/or program; global experience preferred
• Experience managing a study from start to completion, finance/budget experience, managing multiple phases, and managing the full project life cycle
• Demonstrated understanding of therapeutic and protocol disciplines in Dermatology, ICH/GCP regulations, FDA guidance documents/EU directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures

•  Premier Research is more than a company–it’s a community of people that truly care
  about one another, about our clients, and about our mission of furthering research to
  improve the lives of patients in critical need.
• Our cultural anchors–Caring & Empathy, Empowerment, Aspiration, One Team–mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

Description

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.

We’re looking for a Medical Director - Rare Diseases & Paediatrics to join our Medical Management team that is passionate about improving healthcare through innovative clinical research.

As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.

At Premier Research, we are science-minded and heart-centered. Join us.

We can consider hiring this position in any location across Europe where we have an office presence.

What you'll be doing:

• You will support our growing pediatric/rare disease portfolio and will be a key figure within the medical team providing medical monitoring, therapeutic oversight to study programs, supporting Business Development activities aimed at winning new business, and providing input to consulting projects for Premier Research.
• Provides Medical and Safety monitoring on projects.
• Reviews medical/scientific data as requested from Premier Departments
• Provides expert advice and detailed clinical development strategies for allocated projects, including protocol development, study design, investigator brochure development, regulatory strategy and submission, and study execution strategies.
• Provides expert input on RFP/RFI, including (but not limited to) therapeutic overview, executive summary, patient recruitment, strategy and protocol considerations and study execution strategy as needed.
• Attends client meetings in conjunction with specific proposals or general capabilities presentations as needed.
• Raises the profile and image of Premier Research within the Pharmaceutical and Medical Device industry by representing the company in scientific/industry meetings, present and chairing panel presentations, contributing to the publications on peer-reviewed scientific and industry journals.

• Degree of Medicine / Medical Doctor degree, or equivalent.
• Board certification/equivalent in a relevant therapeutic area is an advantage (Pediatrics, Genetics, Internal Medicine, Gastroenterology).
• Prior experience in a CRO or Pharma in a similar role is strongly preferred.
• Expert level of knowledge in the main field of interest and/or assigned therapeutic area, together with a thorough working knowledge in pharmaceutical medicine or medical device fields, clinical development, GCP and regulations pertinent to clinical research.  
• Good business acumen within the CRO and drug development environment

Description

What you’ll be doing:

• Successful management and coordination of efforts assigned to all members of the project team, including but not limited to Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety, to support milestone achievement and overall project delivery
• Adherence to project budget and scope of work to realize project profitability
• All project tasks completion in accordance with project plans and in compliance with global and consistent Premier Research processes, policies, and procedures
• Project risks identification and mitigation
• Effective communication, and project status reports and monthly progress reports are provided both internally and externally
• Compliance for project-related training
• Adequate resourcing to meet project deliverables and milestones
• Representation at client meetings along with commercial colleagues to help win new business

You’ll need this to be considered:

• Bachelor’s degree preferably in a clinical, biological or science-related field from an accredited college or university, or equivalent combination of education and experience
• Demonstrated clinical research experience
• Strong global project management experience, preferably with a CRO
• Gene and Cell Therapy experience is required
• Experience managing a study from start to completion, managing multiple phases, and managing the full project life cycle
• Budget/finance/costing experience on a project level
• Demonstrated understanding of therapeutic and protocol disciplines, ICH/GCP regulations, FDA guidance documents/EU directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures
• A highly confident and effective presenter, fluent in English with strong oral and written communication skills and proficiency with web-based communication tools

Why choose Premier Research?

• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.  
• Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location. 
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful. 

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, or veteran status.

#LI-BC1
#Remote

Description

What you’ll be doing:

• Successful management and coordination of efforts assigned to all members of the project team, including but not limited to Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety, to support milestone achievement and overall project delivery
• Adherence to project budget and scope of work to realize project profitability
• All project tasks completion in accordance with project plans and in compliance with global and consistent Premier Research processes, policies, and procedures
• Project risks identification and mitigation
• Effective communication, and project status reports and monthly progress reports are provided both internally and externally
• Compliance for project-related training
• Adequate resourcing to meet project deliverables and milestones
• Representation at client meetings along with commercial colleagues to help win new business

You’ll need this to be considered:

• Bachelor’s degree preferably in a clinical, biological or science-related field from an accredited college or university, or equivalent combination of education and experience
• Demonstrated clinical research experience
• Strong global project management experience, preferably with a CRO
• Gene and Cell Therapy experience is required
• Experience managing a study from start to completion, managing multiple phases, and managing the full project life cycle
• Budget/finance/costing experience on a project level
• Demonstrated understanding of therapeutic and protocol disciplines, ICH/GCP regulations, FDA guidance documents/EU directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures
• A highly confident and effective presenter, fluent in English with strong oral and written communication skills and proficiency with web-based communication tools

Why choose Premier Research?

• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.  
• Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location. 
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful. 

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, or veteran status.

#LI-BC1
#Remote

Description

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today. 

We’re looking for an Invoice Specialist to join our Functional Services team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.

This position has working hours of 11am-7pm or 12pm-8pm local time in Slovakia.

Working at Premier Research means being an individual - you will be recognized for your expertise, and you will truly have an impact. You will be working in an aspiring and empowering environment with colleagues who are genuinely supportive regardless of location or seniority. Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!

What you’ll be doing:

• Oversee investigator payment reimbursement
• Review, verify, and approve invoices in accordance with standard operating procedures
• Ensure additional necessary invoice approvals are obtained from management
• Query anomalies on invoices and escalate
• Track invoice statuses in Microsoft Excel and provide standard and ad hoc reports to management
• Track individual workload in Microsoft Excel template and provide monthly workload metrics to management.

You’ll need this to be considered:

• Bachelors degree preferably in a financial field, along with up to 5 years of practical experience processing invoices for clinical trial sites, clinical trial investigators, clinical research organizations, pharmaceutical companies, or medical device companies. 
• Demonstrates excellent English verbal and written communication skills
• Excellent computer skills in a Microsoft Windows environment including proficiency in the Microsoft Office Suite of tools (eg - Outlook, Work, Excel, etc)
• Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership
• Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities
• Previous project management experience preferred

Why choose Premier Research?  

• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need. 
• Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve. 

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

#LI-KT1

Description

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.

We’re looking for an Associate Database Developer to join Functional Services team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.

Position Summary:

Assists with the development of project databases, tools and utilities for the Data Management department using the Clinical Data Management Systems (CDMS) and underlying database platforms. To serve as a member of the project team with primary responsibility for database design, validation and data extraction programming.

What you’ll be doing:

• Creates electronic Case Report Forms (eCRFs) according to finalized protocols and study design specifications for Electronic Data Capture (EDC) studies
• Creates data entry screens according to the approved annotated Case Report Form (CRF) for paper studies
• Communicate with data management and study management teams throughout all study start up activities to ensure team needs are understood and met.
• Designs, builds, and tests clinical databases according to Standard Operating Procedures (SOPs)
• Programs field derivations, edit checks, consistency checks, validations, procedures and rules.
• Writes data extraction programs
• Develops of study reporting environment which includes CRF and non-CRF (loaded) data in addition to transforming collected data to required reporting format.
• Produces database documentation including an annotated CRF
• Ensures database documentation is maintained for the Trial Master File (TMF)
• Works in collaboration with the sponsor and study team to define all technical elements of the Data Management Plan
• Performs system testing and Quality Control (QC) of specified deliverables
• May assist in maintaining the Clinical Data Management Systems global and program libraries
• May be required to undertake additional programming tasks as needed
• May be required to participate in a flexible coverage schedule based on business need
• Performs additional duties as assigned

What we are searching for:

• Bachelor degree, or international equivalent from an accredited institution, preferably in a technical field, or equivalent combination of education, training and experience
• 0 to 3 years of practical experience using commercial clinical data management systems and/or EDC products (eg - Oracle RDC / Inform, Medidata Rave, DataLabs, etc).  Alternately, must have proven experience in all primary job functions.
• SQL programming experience is considered an advantage
• Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership
• Demonstrates excellent English verbal and written communication skills
• Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities
• Familiarity with drug development and clinical trial processes preferred

Why choose Premier Research? 

• Premier Research is more than a company –it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
• Our cultural anchors –Caring & Empathy, Empowerment, Aspiration, One Team –mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, or veteran status.

Description

What you’ll be doing:

• Successful management and coordination of efforts assigned to all members of the project team, including but not limited to Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety, to support milestone achievement and overall project delivery
• Adherence to project budget and scope of work to realize project profitability
• All project tasks completion in accordance with project plans and in compliance with global and consistent Premier Research processes, policies, and procedures
• Project risks identification and mitigation
• Effective communication, and project status reports and monthly progress reports are provided both internally and externally
• Compliance for project-related training
• Adequate resourcing to meet project deliverables and milestones
• Representation at client meetings along with commercial colleagues to help win new business

You’ll need this to be considered:

• Bachelor’s degree preferably in a clinical, biological or science-related field from an accredited college or university, or equivalent combination of education and experience
• Demonstrated clinical research experience
• Strong global project management experience, preferably with a CRO
• Gene and Cell Therapy experience is required
• Experience managing a study from start to completion, managing multiple phases, and managing the full project life cycle
• Budget/finance/costing experience on a project level
• Demonstrated understanding of therapeutic and protocol disciplines, ICH/GCP regulations, FDA guidance documents/EU directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures
• A highly confident and effective presenter, fluent in English with strong oral and written communication skills and proficiency with web-based communication tools

Why choose Premier Research?

• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.  
• Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location. 
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful. 

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, or veteran status.

#LI-BC1
#Remote

Description

• Ensures successful management and coordination of efforts assigned to all members of the project team, including but not limited to Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety, to support milestone achievement and overall project delivery 
• Maintains and evaluates study progress by using company tracking systems, project timelines and budget reviews and projecting profitability  
• Manages the project team to ensure study progress is according to both client and Premier Research requirements and in compliance with standard Premier Research processes, policies and procedures 
• Ensures effective communication is maintained and project status reports and monthly progress reports are provided both internally and externally 
• Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training 
• Prepares forecasts for staff utilization over the life of the study and ensures adequate resourcing is available to meet project deliverables and milestones 

• 2 years of Gene and Cell Experience
• Bachelor’s degree preferably in a clinical, biological or science-related field from an accredited college or university, or equivalent combination of education and experience 
• 8 years of clinical research experience
• 5 years of project management experience, preferably with a CRO
• Experience working globally

Description

Join Premier Consulting, a division of Premier Research, and be a part of a strategic product development and global regulatory consulting company dedicated to helping biotech innovators transform their life-changing ideas and breakthrough science into new medical treatments. Our end-to-end solutions in strategy, regulatory, nonclinical, clinical, CMC, quality, and commercial help sponsors build and execute development plans that meet regulatory requirements and deliver results for sponsors and the patients they serve.  

We’re seeking a Senior Director, Medical Writingthat is passionate about driving innovation from the earliest stages of development. As a member of the Premier Consulting team, you’ll build cross-functional partnerships that enable your growth and success. Help us create tangible solutions for patients in need. 

What you'll be doing:

• ​​​Oversees the day-to-day activities of the entire Medical Writing Department 
• ​​Develops organizational policies and authorizes their implementation and follow relevant styles and references in support of the company’s product development plans and objectives 
• ​Takes the initiative to liaise with other departments to share information about medical writing services and capabilities 
• ​Assist in business development-related activities, such as review of request for proposals (RFPs) from various clients, preparation of bid proposals, and review of consulting agreements 
• ​Address any sponsor concerns regarding medical writing deliverables and foster client relationships 
• ​Provide direction to senior managers in various areas, groups, and/or operations. Recognized as an influential leader. Interpret and train others regarding current regulatory guidelines pertaining to regulatory documents 

What we are searching for:

• ​​​​BS/BA or MS degree and 12-14 years of direct medical/technical regulatory writing experience, or PhD and 6+ years’ experience in medical/technical regulatory writing 
• ​6+ years leading medical writing teams 
• ​5-7 years personnel management experience 
• ​International regulatory experience (EMA, TGA, PMDA) 
• ​Extensive understanding of study design, GCP, reporting and regulatory requirements (FDA/EMA/Health Canada/TGA/PMDA) 
• ​Extensive knowledge and experience with Common Technical Document content templates as well as content expectations for IND/NDA/BLA/MAA and other regulatory documentation 

Why Choose Premier Consulting, a division of Premier Research?

• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
• Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.  

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others. 

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, or veteran status. 

#LI-EC

Description

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today. 

We’re looking for a Project Manager II / Senior Project Manager to join our Oncology Project Delivery team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success. 

What you’ll be doing:  

• Ensures successful management and coordination of efforts assigned to all members of the project team, including but not limited to Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety, to support milestone achievement and overall project delivery 
• Maintains and evaluates study progress by using company tracking systems, project timelines and budget reviews and projecting profitability  
• Manages the project team to ensure study progress is according to both client and Premier Research requirements and in compliance with standard Premier Research processes, policies and procedures 
• Ensures effective communication is maintained and project status reports and monthly progress reports are provided both internally and externally 
• Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training 
• Prepares forecasts for staff utilization over the life of the study and ensures adequate resourcing is available to meet project deliverables and milestones 

What we are searching for in a Project Manager II:   

• Bachelor’s degree preferably in a clinical, biological or science-related field from an accredited college or university, or equivalent combination of education and experience 
• 6 years of clinical research experience
• 3 years of project management experience, preferably with a CRO

What we are searching for in a Senior Project Manager:   

• Bachelor’s degree preferably in a clinical, biological or science-related field from an accredited college or university, or equivalent combination of education and experience 
• 8 years of clinical research experience
• 5 years of project management experience, preferably with a CRO
• Experience working globally

Why choose Premier? 

• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and most importantly about our mission of furthering research to improve the lives of patients in critical need.
• Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

At Premier Research, our mission is to improve healthcare by transforming life-changing ideas into new medical treatments that address the unmet needs of a diverse global population. Achieving this is impossible without creating a culture where our employees are given the power to think creatively, challenge ideas, and solve complex problems fearlessly.

Through a commitment to diversity, equity, inclusion, and empowerment, we strive to create a community of belongingness where our differences are welcomed and celebrated. It fuels our innovation and better connects us to the patients, physicians, and customers we serve.

Description

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today. 

We’re looking for a Senior Project Manager to join our Analgesia Project Delivery team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success. 

What you’ll be doing:  

• Ensures successful management and coordination of efforts assigned to all members of the project team, including but not limited to Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety, to support milestone achievement and overall project delivery 
• Maintains and evaluates study progress by using company tracking systems, project timelines and budget reviews and projecting profitability  
• Manages the project team to ensure study progress is according to both client and Premier Research requirements and in compliance with standard Premier Research processes, policies and procedures 
• Ensures effective communication is maintained and project status reports and monthly progress reports are provided both internally and externally 
• Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training 
• Prepares forecasts for staff utilization over the life of the study and ensures adequate resourcing is available to meet project deliverables and milestones

What we are searching for in a Senior Project Manager:   

• Bachelor’s degree preferably in a clinical, biological or science-related field from an accredited college or university, or equivalent combination of education and experience 
• 8 years of clinical research experience
• 5 years of project management experience, preferably with a CRO
• Experience working globally

Why choose Premier? 

• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and most importantly about our mission of furthering research to improve the lives of patients in critical need.
• Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

At Premier Research, our mission is to improve healthcare by transforming life-changing ideas into new medical treatments that address the unmet needs of a diverse global population. Achieving this is impossible without creating a culture where our employees are given the power to think creatively, challenge ideas, and solve complex problems fearlessly.

Through a commitment to diversity, equity, inclusion, and empowerment, we strive to create a community of belongingness where our differences are welcomed and celebrated. It fuels our innovation and better connects us to the patients, physicians, and customers we serve.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status. 

Description

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.

We’re looking for a Technical Data Manager to join our Functional Services team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.

At Premier Research, we are science-minded and heart-centered. Join us.

This is a Contractor opportunity, anticipated to be over a year-long. 

• Develops and maintains clinical data standards, including operational (electronic Case Report Form (CRF) global library standards), Study Data Tabulation Model (SDTM), controlled terminology, external data mappings (e.g., lab or electrocardiogram), and other applicable standards
• Works across the portfolio and Clinical Study Teams to increase automated reporting (JReview®, SAS) and review in order to streamline effort on data intensive studies
• Develops of 'smart' reports, identifies efficiencies and trends in ongoing review, and develops best practices and data flow solutions
• Enhances available reporting tools or creates new ones to support the review of clinical trial data and trial status information for cross-functional use
• Creates Standard Operating Procedures (SOPs), best practices, educational series, global work streams related to data standards, trial/data status reporting and clinical database creation and testing
• Leads/performs activities related User and Site Account Administration and Maintenance within Clinical Data Management Systems (CDMS) and Electronic Data Capture (EDC) including the definition of best practices and SOPs
• Leads/performs Clinical Trial Management System (CTMS) Technical Administration including the definition of best practices and SOPs
• Ensures vendors support technical data management activities to meet or exceed industry standards related to clinical data collection, processing and quality
• Liaises with Clinical Research Organizations, EDC vendors and other third-party vendors in a project-manager capacity in support of timelines and data-related technical deliverables.
• Performs additional duties and assignments as designated.

• Bachelor degree, or international equivalent from an accredited institution, preferably in a programming, technical, clinical, or health-related field, or equivalent combination of education, training and experience
• 3 to 5 years of practical experience using commercial clinical data management systems (eg – Oracle RDC / Inform, Medidata Rave, Datalabs, etc) or data visualization tools (e.g. Spotfire, jReview).
• Demonstrates excellent English verbal and written communication skills
• Excellent computer skills in a Microsoft Windows environment including proficiency in the Microsoft Office Suite of tools (eg - Outlook, Work, Excel, etc)
• Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership
• Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities
• Practical experience with CDISC SDTM preferred
  

Description

• Join Premier Consulting, a division of Premier Research, and be a part of a strategic product development and global regulatory consulting company dedicated to helping biotech innovators transform their life-changing ideas and breakthrough science into new medical treatments. Our end-to-end solutions in strategy, regulatory, nonclinical, clinical, CMC, quality, and commercial help sponsors build and execute development plans that meet regulatory requirements and deliver results for sponsors and the patients they serve.
  
  We're looking for an Associate Director, Business Development to join our Business Development team! This is a permanent role and can be located anywhere in the US. 
  
  What you'll be doing:
  
  • Engaging effectively with the prospect’s C-suite and key project stakeholders to develop relationships.
  • Discover information about business environment and decision making; company and project goals; product pipeline and priorities; and specific product development and regulatory needs.
  • Introduce Premier Consulting and its solution capabilities to develop prospect’s knowledge of and confidence in Premier Consulting's expertise and differentiation.
  • Bridge between business and scientific issues to ensure project opportunities are designed to effectively address critical business, development and regulatory goals.
  • Work with Sales Operations and Finance teams to prepare and price proposals in a timely manner.
  • Present proposals to prospects. Identify and overcome objections. Negotiate key terms to advance opportunities.
  • Influence prospect decision making at critical times in the business development process by leveraging scientific colleagues to complete solution design and demonstrate Premier Consulting's expertise.
  • Manage client onboarding collaboratively with other internal stakeholders to foster positive client experience and enable successful project kick-offs.
  • Share learnings with Marketing team and Development and Regulatory team about market segments, buyer personas, and prospect needs to influence solution design and enable successful lead generation.
  • Utilize CRM throughout the business development process to drive personal and team productivity. Update all Opportunity, Account, and Contact records appropriately to reflect business activity.
  • Manage pipeline effectively to maintain opportunity velocity and optimize personal production against goals. Respond to all prospect requests in a timely manner.
  • Prepare regular forecasts to improve visibility of future contract signings and revenue.
  • Effectively transition newly signed customers to Program Management and Operations teams
  • Travel to industry events throughout the year; low travel requirements
  You'll need this to be considered:
  
  • Knowledge and skills at a level normally acquired through the completion of a Bachelor’s, Master’s or PhD in a scientific field required.
  • 5+ years’ experience sales experience with a CRO or similar organization that supports biopharma research and development.
  • Consultative sales experience with successful track record of performance against quotas and related goals.
  • Understanding of the mechanisms and processes of drug development and approval n the United States preferred.:
  • Ability to travel as needed for inter-office, conferences, trade shows, and client meetings. Travel is expected to be <25%.
  Why choose Premier Research?  
  
  • Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need. 
  • Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
  • Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
  Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve. 
  
  We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
  
  Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.