Description

Premier Research is looking for an Executive Director, Program Delivery to join our Neuroscience team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
• We are Built by You. Your ideas influence the way we work, and your voice matters here.
• We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Together, we are Built for Biotech^SM. Join us and build your future here.

The Executive Director, Program Delivery operates at a strategic support level for complex, critical therapeutically aligned programs through key stakeholder engagement and cross functional management. The Executive Director, Program Delivery empowers assigned PMs/PDs to lead and direct global cross-functional teams and manage client expectations to achieve client satisfaction. This role ensures operational excellence in collaboration with leadership and in support of the overall franchise responsibility. Further, this position leads the PMs/PDs assigned on clinical studies or clinical program in the Neuroscience therapeutic area.

What you'll be doing:

• Mentors and supports the Project Delivery staff (Project Managers and Project Directors) assigned in the Neuroscience therapeutic area; provides leadership to direct reports within the Franchise, from both career development and therapeutic area perspectives
• Ensures adequate resourcing and successful management to support milestone achievement and overall program delivery to the customer; ensures effective communication is maintained and program status reports are provided both internally and externally
• Ensures adherence to program budget and scope of work 
• Ensures all program tasks are completed in accordance with program plans and in compliance with standard Premier Research processes, policies and procedures

What we are searching for:

• BS degree, or international equivalent from an accredited institution, in a clinical, scientific, or health-related field (life science preferred)
• 10+ years project management experience in a pharmaceutical company/medical device company/CRO
• 7+ years supervisory/management experience; experience in coaching/mentoring other PMs
• Advance knowledge of Neuroscience therapeutic area

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-KH1
#LI-Remote 

Description

Premier Research is looking for a Executive Director, Program Strategy to join our General Medicine team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
• We are Built by You. Your ideas influence the way we work, and your voice matters here.
• We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Together, we are Built for Biotech^SM. Join us and build your future here.

As the Executive Director, Program Strategy, you’ll have the opportunity to showcase your strategic and therapeutic expertise to advise, consult, plan and direct the design and strategy of new business opportunities and provide consultative services to customers. You’ll also support the Business Development and Operations efforts for key customers, and provide support and input as it relates to the RFP process.

What you’ll be doing:

• Strategize with Business Development for all proposal development support related to Gen Med studies; lead and partner with Operations and Business Development for planning of bid defense and capability meetings
• Review RFP’s, assess monitoring strategies and resources to support budget development
• Develop and improve the pricing and related strategies that provide the best scenario to meeting project margins on successfully awarded work
• Ensure compliant and profitable project delivery that meets or exceeds customer and industry standards
• Develop and foster relationships with existing/potential clients and networks aligned with Gen Med

What we are searching for:

• Bachelor's degree (PhD or MS strongly preferred) in a clinical, science or health related field along with 10-12 years in Clinical Trials Experience including 5 years in a CRO or pharmaceutical environment
• SME in designing and/or managing clinical trials in General Medicine, which includes strong knowledge of regulatory, scientific, technical, and clinical operations; extensive knowledge of the commercial and regulatory environments in the area of Gen Med
• In depth experience in public speaking and presentation delivery; excellent verbal and written communications skills with an ability to distill scientific or medical concepts into compelling and differentiating strategies
• Able to motivate and manage a number of stakeholders and contributors to meet deadlines and to produce a winning service proposal and high quality work
• Must be available to perform up to 50-65% of overnight business travel, both domestic and international

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-KH1
#LI-Remote

Description

Premier Research is looking for a Senior Manager, Clinical Management to join our Clinical Operations team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
• We are Built by You. Your ideas influence the way we work, and your voice matters here.
• We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Together, we are Built for Biotech^SM. Join us and build your future here.

As the Senior Manager, Clinical Management,you will be responsible for the direct line management and supervision of our Clinical Lead staff including skills assessment, training, resourcing, performance evaluation and career development. You'll also have the opportunity to provide leadership in the implementation of operational management activities. In addition, you may serve as regional point of contact collaborating cross-functionally with internal stakeholders and serving as local liaison for external clients.

What you’ll be doing:

People:

• Provide all aspects of line management supervision to Clinical Leads, including, but not limited to, administrative oversight (timesheets/expense report review), performance management (quality, quantity and timeliness of work performed), appraisals, and professional development
• Provide effective support and training to ensure high performing staff, adherence to corporate policy, federal and local guidelines and ICH GCPs and high quality, on time delivery
• Ensure proper utilization and resourcing of all direct reports including interfacing with Project Management and Resourcing regarding assignments and workload
• Collaborate with all functional area representatives, project team and external stakeholders as needed to ensure alignment across functions
• Proactively seek input on project-specific performance, conduct ongoing review of metrics and key performance indicators (KPIs)

Technical:

• Provide direction to the Clinical Leads on the operational delivery for clinical projects; mentors direct reports on project financial tracking and reporting
• Function as a key resource for resolution of clinical issues and support project escalations
• Utilize technology and data sources available to proactively identify and mitigate emerging risks
• Provide support for both internal and external audits as required, including audit preparedness
• Participate in the creation and maintenance of clinical management process documents including SOPs and associated documents for clinical operations
• May support Business Development activities as required

• Undergraduate degree or equivalent in clinical, science or health related field
• 8+ years relevant experience including clinical research experience in a CRO environment
• 3+ years of direct line management experience, specifically managing people at the Clinical Lead/Clinical Trial Manager level
• Prior working experience as a Clinical Lead/Clinical Trial Manager
• Must be able to travel up to 25%, as required

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-KH1
#LI-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 a Project Manager to join our Medical Device 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:

• 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
• Clinical Research experience, preferably in a CRO/pharmaceutical company/medical device company, at least half of which has been in a matrix environment
• Min. 2 years of experience serving as a Project Manager for complex and/or international clinical trials and/or program; global experience preferred
• Demonstrated understanding of therapeutic and protocol disciplines in Oncology, ICH/GCP regulations, FDA guidance documents/EU directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures
• Skilled at multitasking and working effectively in a fast-paced environment with competing priorities to meet deadline, and address problems decisively and objectively
• 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 medtech 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

#Remote
#LI-BC1

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 to join our Medical Device 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:

• 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
• Clinical Research experience, preferably in a CRO/pharmaceutical company/medical device company, at least half of which has been in a matrix environment
• Min. 2 years of experience serving as a Project Manager for complex and/or international clinical trials and/or program; global experience preferred
• Demonstrated understanding of therapeutic and protocol disciplines in Oncology, ICH/GCP regulations, FDA guidance documents/EU directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures
• Skilled at multitasking and working effectively in a fast-paced environment with competing priorities to meet deadline, and address problems decisively and objectively
• 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 medtech 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

#Remote
#LI-BC1

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 to join our Medical Device 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:

• 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
• Clinical Research experience, preferably in a CRO/pharmaceutical company/medical device company, at least half of which has been in a matrix environment
• Min. 2 years of experience serving as a Project Manager for complex and/or international clinical trials and/or program; global experience preferred
• Demonstrated understanding of therapeutic and protocol disciplines in Oncology, ICH/GCP regulations, FDA guidance documents/EU directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures
• Skilled at multitasking and working effectively in a fast-paced environment with competing priorities to meet deadline, and address problems decisively and objectively
• 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 medtech 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

#Remote
#LI-BC1

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 to join our Medical Device 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:

• 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
• Clinical Research experience, preferably in a CRO/pharmaceutical company/medical device company, at least half of which has been in a matrix environment
• Min. 2 years of experience serving as a Project Manager for complex and/or international clinical trials and/or program; global experience preferred
• Demonstrated understanding of therapeutic and protocol disciplines in Oncology, ICH/GCP regulations, FDA guidance documents/EU directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures
• Skilled at multitasking and working effectively in a fast-paced environment with competing priorities to meet deadline, and address problems decisively and objectively
• 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 medtech 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

#Remote
#LI-BC1

Description

Premier Research is looking for aSenior Clinical Data Manager to join our Functional Servicesteam. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.  

• We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.  
• We are Built by You. Your ideas influence the way we work, and your voice matters here.  
• We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.  

Together, we are Built for Biotech.Join us and build your future here.  

What You'll Be Doing:

• Assists in preparing clean databases by performing a review of clinical trial data through the CDMS or external data listings to ensure all captured data follows the rules outlined by the protocol and Data Management Plan
• Provide input to and review of Data Management Plans in support of clinical study deliverables
• Generates queries to appropriate internal or external personnel (e.g. - investigational sites, vendors, Clinical Research Associates, and client representatives) to resolve problematic data identified during every aspect of the data management process
• Reviews responses to queries for appropriateness, resolves any discrepancies, and modifies the database accordingly
• Supports the development of CRFs and edit check specifications per protocol and participates in user acceptance testing of CRFs and associated edit check specifications as required
• Prepares and maintains documentation related to CRF, edit check, and data listing testing including initial testing and follow-up testing to ensure that the changes have been made, as required

• Bachelor degree, or international equivalent from an accredited institution, preferably in a technical, clinical, or health-related field], or equivalent combination of education, training and experience 
• 3+ years of practical experience using commercial clinical data management systems and/or EDC products (eg - Oracle RDC / Inform, Medidata Rave, DataLabs, etc).  
• Must have 2+ years of oncology study experience
• Demonstrates excellent English verbal and written communication skills 
• 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 

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

Premier Research is looking for a Senior Clinical Research Associate to join our Functional Services team.You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.  

• We are Built for You.We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.  
• We are Built by You.Your ideas influence the way we work, and your voice matters here.  
• We are Built with You.As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.  

Together, we are Built for BiotechSM.Join us and build your future here.  

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 a thorough comparison (monitor) of case report forms against medical records on complex trials at multiple sites.
• Addresses non-compliance issues and trends at investigative site; develops, docu­ments, and implements a CAP as necessary.

Role: Quality and Process Improvement Champion

• Identifies and Reports complaints.
• 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.

What We Are Searching For:

• Must have 4 year Bachelor's Degree
• Must have at least 6+ years of independent monitoring experience
• Must have knowledge of applicable clinical research regulations (FDA, GCP, ISO)
• Must be able to travel 50-75% nationally
• Must have direct sponsor experience at a pharma or biotech
• Strong communication and organizational skills required

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

• Responsible for developing the Regulatory & start-up submission project plan.  Is the driver for CA, EC and LEC submission as well other boards/evaluating bodies, import and export licenses, where applicable.
• Is the liaison with the Sponsor regarding approval and collection of all core documents, country submission packages and commination and adherence to timelines and deliverables
• Responsible for identifying & communicating country timelines to our clients and project teams
• Generates and obtains appropriate Sponsor approval for master core documentation e.g. Submission cover letters and EudraCT xml etc.
• Ensures continuous improvement of quality in all Regulatory and Start-up components at the project level (clinical trial applications, essential document collection, communication to Competent Authority and Ethics Committees, etc.).
• Assumes responsibility on deliverables in Regulatory and Start-up at the project level following the project requirements and the applicable rules.
• Complies with forecasted submission/approval timelines; if forecasted timelines are not reached or if any potential issue is identified, escalates the problem as soon as identified and provides suggestions for resolution
• Produces and/or reviews submission components like the Patient Information Form/ICF.
• To the level of competence of the RSM, may participate in the review of the Investigational Medicinal Product Dossier (IMPD) in conjunction with other Subject Matter Experts
• May serve as an Independent Essential Document Reviewer and/or perform second pass review of Essential Documents.
• Attends Kick-Off Meeting, when required

What you’ll need:

• 5+ years study start-up experience
• Min. 2 years in the global study start up role
• Experience in leading teams
• Bachelor's degree in Life Science or similar
• Excellent communication skills
• Ability to work in the team and to prioritize
• Experience working on ample number of countries in global studies with a working knowledge of FDA Guidance Documents/EU Directives/ISO14155 regulations, drug/device development, and start-up procedures
• The ability to develop a collaborative team environment and maintain strong cross-functional relationships that enable effective and creative problem solving

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 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.

Description

• Responsible for developing the Regulatory & start-up submission project plan.  Is the driver for CA, EC and LEC submission as well other boards/evaluating bodies, import and export licenses, where applicable.
• Is the liaison with the Sponsor regarding approval and collection of all core documents, country submission packages and commination and adherence to timelines and deliverables
• Responsible for identifying & communicating country timelines to our clients and project teams
• Generates and obtains appropriate Sponsor approval for master core documentation e.g. Submission cover letters and EudraCT xml etc.
• Ensures continuous improvement of quality in all Regulatory and Start-up components at the project level (clinical trial applications, essential document collection, communication to Competent Authority and Ethics Committees, etc.).
• Assumes responsibility on deliverables in Regulatory and Start-up at the project level following the project requirements and the applicable rules.
• Complies with forecasted submission/approval timelines; if forecasted timelines are not reached or if any potential issue is identified, escalates the problem as soon as identified and provides suggestions for resolution
• Produces and/or reviews submission components like the Patient Information Form/ICF.
• To the level of competence of the RSM, may participate in the review of the Investigational Medicinal Product Dossier (IMPD) in conjunction with other Subject Matter Experts
• May serve as an Independent Essential Document Reviewer and/or perform second pass review of Essential Documents.
• Attends Kick-Off Meeting, when required

What you’ll need:

• 5+ years study start-up experience
• Min. 2 years in the global study start up role
• Experience in leading teams
• Bachelor's degree in Life Science or similar
• Excellent communication skills
• Ability to work in the team and to prioritize
• Experience working on ample number of countries in global studies with a working knowledge of FDA Guidance Documents/EU Directives/ISO14155 regulations, drug/device development, and start-up procedures
• The ability to develop a collaborative team environment and maintain strong cross-functional relationships that enable effective and creative problem solving

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 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.

Description

• Responsible for developing the Regulatory & start-up submission project plan.  Is the driver for CA, EC and LEC submission as well other boards/evaluating bodies, import and export licenses, where applicable.
• Is the liaison with the Sponsor regarding approval and collection of all core documents, country submission packages and commination and adherence to timelines and deliverables
• Responsible for identifying & communicating country timelines to our clients and project teams
• Generates and obtains appropriate Sponsor approval for master core documentation e.g. Submission cover letters and EudraCT xml etc.
• Ensures continuous improvement of quality in all Regulatory and Start-up components at the project level (clinical trial applications, essential document collection, communication to Competent Authority and Ethics Committees, etc.).
• Assumes responsibility on deliverables in Regulatory and Start-up at the project level following the project requirements and the applicable rules.
• Complies with forecasted submission/approval timelines; if forecasted timelines are not reached or if any potential issue is identified, escalates the problem as soon as identified and provides suggestions for resolution
• Produces and/or reviews submission components like the Patient Information Form/ICF.
• To the level of competence of the RSM, may participate in the review of the Investigational Medicinal Product Dossier (IMPD) in conjunction with other Subject Matter Experts
• May serve as an Independent Essential Document Reviewer and/or perform second pass review of Essential Documents.
• Attends Kick-Off Meeting, when required

What you’ll need:

• 5+ years study start-up experience
• Min. 2 years in the global study start up role
• Experience in leading teams
• Bachelor's degree in Life Science or similar
• Excellent communication skills
• Ability to work in the team and to prioritize
• Experience working on ample number of countries in global studies with a working knowledge of FDA Guidance Documents/EU Directives/ISO14155 regulations, drug/device development, and start-up procedures
• The ability to develop a collaborative team environment and maintain strong cross-functional relationships that enable effective and creative problem solving

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 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.

Description

• Responsible for developing the Regulatory & start-up submission project plan.  Is the driver for CA, EC and LEC submission as well other boards/evaluating bodies, import and export licenses, where applicable.
• Is the liaison with the Sponsor regarding approval and collection of all core documents, country submission packages and commination and adherence to timelines and deliverables
• Responsible for identifying & communicating country timelines to our clients and project teams
• Generates and obtains appropriate Sponsor approval for master core documentation e.g. Submission cover letters and EudraCT xml etc.
• Ensures continuous improvement of quality in all Regulatory and Start-up components at the project level (clinical trial applications, essential document collection, communication to Competent Authority and Ethics Committees, etc.).
• Assumes responsibility on deliverables in Regulatory and Start-up at the project level following the project requirements and the applicable rules.
• Complies with forecasted submission/approval timelines; if forecasted timelines are not reached or if any potential issue is identified, escalates the problem as soon as identified and provides suggestions for resolution
• Produces and/or reviews submission components like the Patient Information Form/ICF.
• To the level of competence of the RSM, may participate in the review of the Investigational Medicinal Product Dossier (IMPD) in conjunction with other Subject Matter Experts
• May serve as an Independent Essential Document Reviewer and/or perform second pass review of Essential Documents.
• Attends Kick-Off Meeting, when required

What you’ll need:

• 5+ years study start-up experience
• Min. 2 years in the global study start up role
• Experience in leading teams
• Bachelor's degree in Life Science or similar
• Excellent communication skills
• Ability to work in the team and to prioritize
• Experience working on ample number of countries in global studies with a working knowledge of FDA Guidance Documents/EU Directives/ISO14155 regulations, drug/device development, and start-up procedures
• The ability to develop a collaborative team environment and maintain strong cross-functional relationships that enable effective and creative problem solving

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 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.

Description

• Responsible for developing the Regulatory & start-up submission project plan.  Is the driver for CA, EC and LEC submission as well other boards/evaluating bodies, import and export licenses, where applicable.
• Is the liaison with the Sponsor regarding approval and collection of all core documents, country submission packages and commination and adherence to timelines and deliverables
• Responsible for identifying & communicating country timelines to our clients and project teams
• Generates and obtains appropriate Sponsor approval for master core documentation e.g. Submission cover letters and EudraCT xml etc.
• Ensures continuous improvement of quality in all Regulatory and Start-up components at the project level (clinical trial applications, essential document collection, communication to Competent Authority and Ethics Committees, etc.).
• Assumes responsibility on deliverables in Regulatory and Start-up at the project level following the project requirements and the applicable rules.
• Complies with forecasted submission/approval timelines; if forecasted timelines are not reached or if any potential issue is identified, escalates the problem as soon as identified and provides suggestions for resolution
• Produces and/or reviews submission components like the Patient Information Form/ICF.
• To the level of competence of the RSM, may participate in the review of the Investigational Medicinal Product Dossier (IMPD) in conjunction with other Subject Matter Experts
• May serve as an Independent Essential Document Reviewer and/or perform second pass review of Essential Documents.
• Attends Kick-Off Meeting, when required

What you’ll need:

• 5+ years study start-up experience
• Min. 2 years in the global study start up role
• Experience in leading teams
• Bachelor's degree in Life Science or similar
• Excellent communication skills
• Ability to work in the team and to prioritize
• Experience working on ample number of countries in global studies with a working knowledge of FDA Guidance Documents/EU Directives/ISO14155 regulations, drug/device development, and start-up procedures
• The ability to develop a collaborative team environment and maintain strong cross-functional relationships that enable effective and creative problem solving

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 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.

Description

• Responsible for developing the Regulatory & start-up submission project plan.  Is the driver for CA, EC and LEC submission as well other boards/evaluating bodies, import and export licenses, where applicable.
• Is the liaison with the Sponsor regarding approval and collection of all core documents, country submission packages and commination and adherence to timelines and deliverables
• Responsible for identifying & communicating country timelines to our clients and project teams
• Generates and obtains appropriate Sponsor approval for master core documentation e.g. Submission cover letters and EudraCT xml etc.
• Ensures continuous improvement of quality in all Regulatory and Start-up components at the project level (clinical trial applications, essential document collection, communication to Competent Authority and Ethics Committees, etc.).
• Assumes responsibility on deliverables in Regulatory and Start-up at the project level following the project requirements and the applicable rules.
• Complies with forecasted submission/approval timelines; if forecasted timelines are not reached or if any potential issue is identified, escalates the problem as soon as identified and provides suggestions for resolution
• Produces and/or reviews submission components like the Patient Information Form/ICF.
• To the level of competence of the RSM, may participate in the review of the Investigational Medicinal Product Dossier (IMPD) in conjunction with other Subject Matter Experts
• May serve as an Independent Essential Document Reviewer and/or perform second pass review of Essential Documents.
• Attends Kick-Off Meeting, when required

What you’ll need:

• 5+ years study start-up experience
• Min. 2 years in the global study start up role
• Experience in leading teams
• Bachelor's degree in Life Science or similar
• Excellent communication skills
• Ability to work in the team and to prioritize
• Experience working on ample number of countries in global studies with a working knowledge of FDA Guidance Documents/EU Directives/ISO14155 regulations, drug/device development, and start-up procedures
• The ability to develop a collaborative team environment and maintain strong cross-functional relationships that enable effective and creative problem solving

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 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.

Description

Premier Research is looking for anProject Finance Systems Specialist I to join our Finance team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.  

• We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. 
• We are Built by You. Your ideas influence the way we work, and your voice matters here. 
• We are Built with You. As an essential part of our team, you help us deliver medical innovation that patients are desperate for. 

Together, we are Built for BiotechSM.Join us and build your future here.  

What you’ll be doing: 

• Liaison between Finance teams and Information Technology to advance Finance System project, upgrades, improvements, and support discussions with stakeholders
• Utilizes operational and financial understanding to ensure system configuration and provides efficient and accurate results to management and end users
• Learn all aspects and functionality of finance systems to become a system expert (Costpoint, OneStream, Cobra/PMC, etc.). Administer new project setup in Cobra/PMC and Costpoint inclusive of setup for change order budgets
• Responsible for maintaining meta data for all financial systems such as account, department, PAGs, etc. and all associated hierarchies and develop report specifications for CER report writers
• Provides month end support for the PPA/PFA’s by trouble shooting and providing guidance for system related activities

What we are searching for:  

• Bachelor’s degree, or international equivalent from an accredited institution, in accounting, finance, or information technology
• 1-2 years of experience in accounting or finance, preferably in a service organization
• 1-2 years direct experience in the Clinical Research industry
• Working knowledge of integrated program management systems and ability to create and analyze reports in Microsoft Excel

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.

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. 

#LI-SK1

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 Lead Data Manager 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.


What you'll be doing:

• Responsible for independently leading end-to-end data management activities, including but not limited to, accurate and timely database design, database setup (including CRF and Non- CRF collection tools), data cleaning, and data management documentation
• Prepares the data management plans (DMP), data validation plans, completion guidelines, data management reports and other documents as required
• Participates in and coordinates study team review of CRFs for potential data collection, database structure, or data entry problems as well as to ensures all captured data follows the rules outlined by the protocol and data management plan
• Manages the development of the data validation plan per the protocol and ensures user acceptance testing of CRFs and associated edit checks are completed in accordance with project timelines
• Participates in and manages the progress of data cleaning activities including the generation and resolution of queries and discrepancies
• Ensures the accurate and timely reconciliation of third party data with Clinical Data Management System (CDMS) data.

• Bachelor degree, or international equivalent from an accredited institution, preferably in a technical, clinical, or health-related field], or equivalent combination of education, training and experience
• 5 to 7 years of practical experience leading database management activities and 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.
• Excellent computer skills in a Microsoft Windows environment including proficiency in the Microsoft Office Suite of tools (eg - Outlook, Work, Excel, etc)

• 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

• Responsible for developing the Regulatory & start-up submission project plan.  Is the driver for CA, EC and LEC submission as well other boards/evaluating bodies, import and export licenses, where applicable.
• Is the liaison with the Sponsor regarding approval and collection of all core documents, country submission packages and commination and adherence to timelines and deliverables
• Responsible for identifying & communicating country timelines to our clients and project teams
• Generates and obtains appropriate Sponsor approval for master core documentation e.g. Submission cover letters and EudraCT xml etc.
• Ensures continuous improvement of quality in all Regulatory and Start-up components at the project level (clinical trial applications, essential document collection, communication to Competent Authority and Ethics Committees, etc.).
• Assumes responsibility on deliverables in Regulatory and Start-up at the project level following the project requirements and the applicable rules.
• Complies with forecasted submission/approval timelines; if forecasted timelines are not reached or if any potential issue is identified, escalates the problem as soon as identified and provides suggestions for resolution
• Produces and/or reviews submission components like the Patient Information Form/ICF.
• To the level of competence of the RSM, may participate in the review of the Investigational Medicinal Product Dossier (IMPD) in conjunction with other Subject Matter Experts
• May serve as an Independent Essential Document Reviewer and/or perform second pass review of Essential Documents.
• Attends Kick-Off Meeting, when required

What you’ll need:

• 5+ years study start-up experience
• Min. 2 years in the global study start up role
• Experience in leading teams
• Bachelor's degree in Life Science or similar
• Excellent communication skills
• Ability to work in the team and to prioritize
• Experience working on ample number of countries in global studies with a working knowledge of FDA Guidance Documents/EU Directives/ISO14155 regulations, drug/device development, and start-up procedures
• The ability to develop a collaborative team environment and maintain strong cross-functional relationships that enable effective and creative problem solving

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 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.

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 Neuroscience 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. The position can be filled in Spain.

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 
• Min. 10 years of clinical research experience
• Strong project management experience, preferably with a CRO
• Experience working globally
• Bipolar experience is required

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.

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.

#Remote
#LI-BC1

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 junior team member as a Project Finance Analyst, join our team at Bangalore office. One 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 :

• Administer project set up, maintenance and close-out in finance systems, as well as create internal tracking worksheets
• Calculates monthly revenue and forecast for assigned projects
• Assists and supports team with monthly revenue processing and updating steps
• Supports Project Finance Analyst with time reports and updating of key project financial information
• Works with Project Finance Analyst to provide cost estimates on projects, as requested
• Assist with study close out process
• Ad hoc projects as required       
• Reviews contract payments schedules and prepares monthly fee for service and pass-through invoices to send to Client for assigned projects
• Analyzes contract including, but not limited to budget and hours for appropriate setup in financial system and creation of internal tracking worksheets
• Calculates monthly contract revenue for assigned projects
• Assist Project Managers with analyzing monthly reports for tracking project profitability
• Attends all project related meetings regarding assigned projects
• Calculates monthly backlog for assigned projects
• Assists managers (Project and Finance) and core team member with questions, concerns and analyses of projects as requested
• Analyzes change orders for incorporation into original contract
• Prepares cash flow and analysis for creation of payment schedules

   

What are we looking for:

Educational Background

· Bachelor’s degree in accounting or finance

 Experience

· Minimum  1 to 1.5 years related experience in project finance, preferably from a CRO

· Experience with Deltek Costpoint version 6 preferred but not mandatory

Personal skills & behaviors

· Highly detail oriented

· Strong verbal, written, and interpersonal skills

· Good organizational skills

· Computer skills, particularly in Microsoft Office, Excel

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.