Job Description

We are seeking a recruitment professional who will join our global Talent Acquisition team and play an important role in the recruitment of exceptional talent across multiple functions and geographies.

You will:

• Post and maintain advertisements on career websites and other media platforms
• Source potential candidates via job boards, resume databases and social media
• Screen resumes and credentials for appropriate skills and experience in relation to position requirements
• Schedule and organize interviews across departments
• Perform initial candidate screening, conduct and report on first stage interviews for entry- and mid-level positions
• Develop candidate pipelines for open and future opportunities within PSI
• Maintain a database of applicants and interview outcomes using the applicant tracking system
• Communicate with hiring managers to understand the position requirements and introduce applicable candidates

Qualifications

• Bachelor's degree in HR or related field or an equivalent combination of education, training, and experience
• Talent sourcing and recruiting experience or at least 2 years of experience in business administration and support services
• Full working proficiency in English (written and spoken)
• Clinical Research, Pharma, or Biotech industry experience is a plus
• Proficiency in MS Office (Word, Excel, PowerPoint, Outlook)
• Experience using an Applicant Tracking System

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Job Description

SEO Manager (Site Enabling Organization Manager) is responsible for the operational stage of research at the contracted clinical sites. They ensure that clinical trials are conducted eefficiently, ethically and in compliance with all relevant guidelines and regulations.

Responsibilities:

• Assess feasibility of research protocols based on knowledge and experience and in accordance with designated criteria to select the most suitable studies for the clinical site.
• Supervise the conduct of clinical trials in accordance with ICH GCP, applicable regulations, procedures, and protocols.
• Monitor individual stages of budget negotiations and research timelines.
• Manage the team of Lead Coordinators, oversee the quality and results of their work.
• Ensure continuous improvement and standardization of the research process, its continuity and consistency with ICH GCP, regulations, procedures and research protocols by co-creating operational procedures, templates, guidelines related to the work of medical staff and the site in clinical studies.
• Supervise and participate, when necessary, in audits and inspections, support the Milestone One team and the medical team at the site by ensuring a reliable and smooth audit process.

Qualifications

• University degree in life sciences.  Business Management degree or certification is a plus
• Recent certified GCP training
• Minimum 5 years of experience in a leadership position at a CRO or SMO
• Fluent use of local language, at least C1 level of English
• Proficiency in MS Office
• Valid driver’s license
• Excellent communications skills
• Excellent leadership and management Skills
• Accountable, result oriented, effective problem solver

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Job Description

The scope of responsibilities will include

Start-up Responsibilities:

• Is involved with in-house and on-site activities related to site identification and new clinical trial placement.

• Is involved in setting clinical trials related collaboration with medical professionals.

• Ensures comprehensive internal handovers from Feasibility to Operations.

• Defines the optimal site profile for a study and recommends the best, high-quality sites after contacting and evaluating their capabilities and potential for study conduct.

• Reviews therapeutic indication, and study specific materials prior to contacting sites.

• Creates and/or maintains a site identification tracker.

• Regularly communicates with Project Teams to update them on the status/progress of the site ID, as well as highlights any potential risks or issues to timelines or objectives.

Ongoing Project Responsibilities (all phases):

• Creates and maintains a therapeutic area-specific site database.

• Assists Project Teams during the enrollment phase by identifying additional sites when necessary.

• Develops strategies to accelerate site identification through the use of external databases like Citeline and CenterWatch, contacting SMOs, site networks, advocacy and support groups and central IRBs etc.

• Training: Trains CTAs and CRAs on how to get the best information from sites, acts as a trainer and mentor.

• Business Development and Corporate assignments: Participates in the preparation of presentations for client and bid defense meetings, provides input in various regulatory aspects (as requested).

Qualifications

Qualifications

• Life sciences degree (proven CRA experience is a plus)

• Experience of working in practical healthcare settings (hospital, outpatient clinic) is a strong plus.

• Prior experience in Site Identification/Study Start-Up activities is a strong plus.

• Practical experience in clinical trials related activities (study coordinator, sub-investigator) is a strong plus.

• Excellent written and oral communication skills, as well as time management skills

• Demonstrates the ability to multitask under compressed deadlines across several projects, each with unique requirements

• Advanced English and native Italian

You are dynamic. You are curious. You are more than your job. For you, excellence isn’t just a word; it’s the measure for all you do. You’re passionate. Driven. Dedicated. You can’t stand mediocrity. And you might be the team member we're looking for.

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Job Description

PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being.

Home-Based in the United States

Responsibilities:

• Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and third-party vendors on medical matters
• Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and different scientific presentations
• Review and analysis of clinical data to ensure the safety of study participants in clinical studies
• Ensure that the reported data is accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendments
• Address safety issues across the study from sites and the study team
• Review listings for coded events to verify Medical Dictionary for Regulatory activities
• Participate in bid defense meetings
• Assist in Pharmacovigilance activities
• Identify Program risks, and create and implement mitigation strategies with Clinical Operations
• Ability to organize and lead clinical development advisory boards and safety monitoring boards
• Ensure Study team compliance with FDA, EMEA, ICH and GCP guidelines
• Review and sign off clinical documents with respect to medical relevance.

Qualifications

• Medical Doctor degree required
• US Board Certification in Nephrology required
• Experience as a practicing Nephrology (minimum of 10 years)
• Full working proficiency in English
• Clinical Research experience preferred
• Proficiency with MS Office applications
• Communication, presentation and analytical skills
• Problem-solving, team and detail-oriented

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Job Description

The official title for this role will be Regional Project Lead.

The Regional Project Lead manages and coordinates activities of project teams in designated countries and ensures consistency of Clinical Operations processes across regions. They ensure meeting study milestones are met by the project team on a country and regional level.

• Ensures planning, implementation, and management of projects in compliance with industry regulations, ICH-GCP, essential study documents, and applicable controlled documents (e.g., PSI QSDs or Sponsor QMS documents)
• Acts as primary or secondary project management contact for the project team and PSI support services in designated countries
• Performs study status review and progress reporting (if delegated by the Project Manager)
• Collects and reports project status updates for designated regions, both internally and externally
• Develops and updates project planning documents, essential study documents and project manuals/ instructions
• Manages and reports on Key Performance Indicators (KPIs) for designated countries and clinical project team members
• Ensures that the project timelines and subject enrollment targets are met in designated countries
• Coordinates maintenance of study-specific and corporate tracking systems
• Coordinates site contractual startup and budget negotiations
• Establishes communication lines within the project team and supervises clinical project team members’ performance
• Identifies, escalates and resolves resourcing and performance issues
• Conducts and supervises therapeutic area training of the project team (if delegated by the Project Manager)
• Prepares presentations and conducts training of Investigators
• Ensures team compliance with project-specific training matrix
• Performs field training of Monitors tailored to the project needs
• Supervises preparation, conduct and reporting of site selection, site initiation, routine monitoring and closeout visits
• Oversees investigator and site payments, as well as CRF data retrieval/ upload and monitoring and the query resolution process
• Supervises project team preparation for study audits/ inspections and resolution of audit/ inspection findings
• Coordinates conduct of supervised monitoring visits
• Reviews site visit reports and ensures monitoring and reporting standards are met 
• Coordinates preparation of initial and follow-up Regulatory and Ethics Committee submissions and notifications
• Oversees the safety information flow and participates in feasibility research
• Reviews/ approves project related expenses and timesheets (if delegated by the Project Manager)

Qualifications

• College/University degree in Life Sciences or an equivalent combination of education, training & experience
• At least 4 years of experience in Clinical Research and site monitoring activities
• At least 2 years of expereince as a Study Manager or Lead with the ability to supervise project activities as a Regional Lead or equivalent
• Experience in Oncology is preferred. 
• Full working proficiency in English
• Proficiency in MS Office applications, including MS Project
• Communication, presentation and customer-service skills
• Ability to negotiate and build relationships at all levels
• Team-building, leadership and organizational skills

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Job Description

This position is open to those based in the San Francisco Bay Area. 

In this position, you will, 

• Actively prospect and leverage potential new business opportunities within specified Customer/Accounts.
• Cultivate strong, long-term relationships with key decision-makers within the Account and develop deep knowledge of the Customer/Account organization.
• Analyze potential opportunities and develop detailed business plans and sales strategies for each Customer/Account. 
• Identify and respond to Customer/Account needs in order to define potential PSI opportunities.  Ensure appropriate strategy/solution is proposed to Customer/Account.
• Work with Operations to identify sales team and prepare presentation.  Educate team participants in Customer/Account culture, operational needs/methods and sales techniques needed to close the sale.
• Lead the entire sales process, including identifying the appropriate team for pitch and preparing and leading the sales presentation.
• Coordinate with the Proposal Development Group to develop proposal and Operations to finalize strategy and pricing.
• Handle follow-up related to the sales and facilitate completion of contractual documents.
• Ensure appropriate hand-off to project team by transferring knowledge on Customer/Account needs and expectations.
• Share Customer/Account strategies and sales plans with Project Directors/Managers.
• Coordinate with Project Managers/Directors and Operations to escalate and quickly address Customer/Account issues/concerns.
• Seek input from Project Managers/Directors to proactively address Change in Scope, new opportunities or customer dissatisfaction.
• Work with Project Manager/Director and Operations to ensure Changes in Scope (CIS’s) are appropriately negotiated with the Customer/Account.
• Maintain high visibility within Customer/Account organization.
• Monitor Customer satisfaction through regular formal and informal surveys.
• Coordinate with Project Managers/Directors to ensure Customer/Account needs are being met and address concerns/issues in a timely manner.
• Review proposals and analyzes requests for proposals and protocols.
• Attend industry events, set up meetings at events, and perform follow-up with potential clients.
• Act as a liaison between Bay Area clients and Operations on an as needed basis.

Salary Range: $100K - $500K 

Qualifications

• University degree in health sciences or an equivalent combination of education, training & experience.
• Demonstrable competency in sales or business development preferably for a Contract Research Organization or company providing services to the healthcare industry.
• 3 - 5 years of business development experience in the CRO sales arena.
• Working proficiency with Salesforce.
• Strong communication, collaboration, problem solving, and time management skills.
• Capable and willing to travel.

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Job Description

We will only consider applications in English language.

• Monitors startup key performance indicators for selected projects on regional/country level
• Identifies and escalates operational issues to Project Management and other functions concerned
• Cooperates with other functions to conduct training and work on process improvement pertaining to study and site startup
• Partakes in the development and update of local instructions and guidelines related to startup activities
• Provides startup support for selected projects - starting from handover to Operations until all sites are activated
• Participates in regional kick-off meetings/calls
• Provides support and technical assistance in feasibility and site identification process
• Coordinates and supports contract negotiation process 
• Coordinates and supports preparation of IP-RED packages
• Performs training of team members tailored to project needs

Qualifications

• College or University degree in Health Sciences or an equivalent combination of education and experience
• At least 2 years of experience in Clinical Research in administrative positions
• Excellent knowledge of regulatory guidelines and ICH GCP
• Communication and interpersonal skills
• Advanced proficiency in English (C1)
• Intermediate proficiency in Spanish (B2)
• Attention to detail and organization skills

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Job Description

The Milestone One Business Development Representative role supports a Business Development department in building and expanding the network of clients according to defined business plans, timelines and goals.

The function of the role includes:

• Building and sustaining long-lasting relationships with existing and potential clients (sponsors, CRO, medical institutions).
• Supporting Site Development Manager with active promotion of Milestone One brand by acquiring new clinics and building a site network.
• Conducting research on potential clients to build extended network.
• Setting up meetings with potential clients to present MO1 business opportunities
• Presenting the benefits of cooperation with Milestone One
• Assisting the Marketing team in the preparation of promotional materials.
• Attending medical/pharmaceutical conferences, and training workshops as required.

Qualifications

Our requirements:

Education: University degree, life science is a plus.

Experience: Minimum 5 years of on-the-job experience in a clinical environment as a medical representative dealing with medical institutions and physicians or as a study coordinator working on site.

Knowledge and skills:

• Fluent use of Polish language, at least B2 level of English
• Proficiency in MS Office
• Excellent communication and presentation skills
• Excellent sales skills
• Effective problem solving and result oriented
• Ability to work in a team
• Valid category B driver’s license

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Job Description

• Coordinates investigator/ site feasibility and identification process, as well as study startup.
• Monitors project timelines and patient enrollment, implements respective corrective and preventive measures.
• Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region.
• Manages Monitors in the query resolution process, including Central Monitoring observations.
• Coordinates safety information flow and protocol/process deviation reporting.
• Performs clinical supplies management with vendors on a country and regional level.
• Ensures study-specific and corporate tracking systems are updated in a timely manner.
• Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager.
• Coordinates planning of supervised monitoring visits and conducts the visits. 
• Manages the project team in site contracting and payments.
• Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager.
• Ensures ongoing evaluation of data integrity and compliance at a country/regional level.
• Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level.
• Oversees project team in CAPA development and implementation.
• Coordinates project team in process deviations review, management and reporting.
• Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs.
• Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead.
• Delivers trainings and presentations at Investigator Meetings.
• Prepares, conducts and reports site selection, initiation, routine monitoring and closeout visits.
• Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level.
• Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations.
• Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level.
• Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level.
• Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level.
• Ensures data integrity and compliance at a site level.
• Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer.
• Conducts project-specific training of site Investigators.
• Supports preparation of draft regulatory and ethics committee submission packages.

Qualifications

• Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience.
• Minimum of 5 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor. 
• Experience with all types of monitoring visits in Phase II and/or III.
• Strong experience in Oncology preferred.
• Experience in CAR-T Therapy or other types of Cell Therapy, Gene Therapy, Radiation Therapy or Radiopharmaceuticals, or Nuclear Medicine is preferred. 
• Full working proficiency in English.
• Proficiency in MS Office applications.
• Ability to plan, multitask and work in a dynamic team environment.
• Excellent Communication, collaboration, and problem-solving skills.
• Ability to travel up to 65% (depending on project needs).
• Valid driver’s license (if applicable).

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Job Description

The Milestone One Business Development Representative role supports a Business Development department in building and expanding the network of clients according to defined business plans, timelines and goals.

The function of the role includes:

• Building and sustaining long-lasting relationships with existing and potential clients (sponsors, CRO, medical institutions).
• Supporting Site Development Manager with active promotion of Milestone One brand by acquiring new clinics and building a site network.
• Conducting research on potential clients to build extended network.
• Setting up meetings with potential clients to present MO1 business opportunities
• Presenting the benefits of cooperation with Milestone One
• Assisting the Marketing team in the preparation of promotional materials.
• Attending medical/pharmaceutical conferences, and training workshops as required.

Qualifications

Our requirements:

Education: University degree, life science is a plus.

Experience: Minimum 5 years of on-the-job experience in a clinical environment as a medical representative dealing with medical institutions and physicians or as a study coordinator working on site.

Knowledge and skills:

• Fluent use of Polish language, at least B2 level of English
• Proficiency in MS Office
• Excellent communication and presentation skills
• Excellent sales skills
• Effective problem solving and result oriented
• Ability to work in a team
• Valid category B driver’s license

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Job Description

The Global Marketing Manager - Europe will help lead the marketing vision, strategy, and development for PSI CRO, championing the brand through digital, traditional, and experiential efforts. They will help connect sales efforts with digital intelligence, collaborate on employment branding, and help direct new efforts toward communicating our company’s unique culture and narrative across the globe.

This dynamic role will report directly to the Senior Director of Global Marketing and be a part of regional and some global Marketing elements within the department: internal, external, sales, and client-facing work. A fast-paced position, it requires excellent interpersonal skills, the ability to think on your feet, and a deep well of new ideas. This rapidly growing team functions as an agency within the company, and has both internal and external clients, so it’s essential that the right fit is comfortable wearing many hats but simultaneously understands both their own values and the company’s culture.

Remote-based in France

RESPONSIBILITIES

• Oversee global account-based marketing and strategy
• Work closely with Business Development on sales support initiatives in Europe
• Manage and maintain PR contacts in industry/paid advertisements/placements in Europe
• Help develop content marketing strategy in support of sales and marketing
• Prioritize engagement with key audiences – KOLs, patients, prospective clients, clients
• Ensure industry and GDPR compliance across all digital channels with web development
• Maintain high attention to detail to ensure accuracy and consistency among all content
• Perform market research (both real-time and traditional) on a regular basis in region and globally

Qualifications

• Bachelor’s degree in communication, journalism, PR, marketing, or related field
• Experience in CRO Marketing and other regulated industry like finance, education, etc.
• Digital management experience
• Experience in a global or cross-regional role
• Effective third-party vendor management experience or experience working in an agency
• Event planning experience is a plus
• Branding experience is a plus
• Strong writing and editing experience, outstanding verbal communication skills
• Executive presence and ability to deliver presentations in small and large groups at all organizational levels
• Capable of managing multiple projects at once with high attention to detail
• Strategic and knowledgeable about digital marketing, advertising regulations within different countries
• Comfortable in a dynamic, fast-paced environment
• Proficient in English

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Job Description

The Lead Data Manager will be responsible for all data management activities in large, complex studies under general supervision, or working under minimal supervision on data management activities for small to medium sized projects. 

 Communication

• Primary communication point for project teams and company departments with regard to clinical data management
• Communication line for clients/vendors for all data management aspects of clinical projects and clinical data management reporting

 Data Management

• Coordination of data management activities within clinical projects related to EDC development, data collection, cleaning, reconciliation, Database Lock, development of final integrated database and generation of final Data Management deliverables. 
• Primary responsibility for clinical data management activities within clinical projects, including, but not limited to:
  • Study documents review
  • Data Management plan and other project-specific guidelines and instructions development and review
  • Co-ordinate/perform user acceptance testing
  • Development of Data Validation Plan/Edit Check Specifications
  • Data entry coordination and supervision, feedback to data entry personnel regarding quality of data entry and other data entry issues
  • Data validation, including automatic and manual data inspections, data discrepancies/deficiencies review and resolution, query generation and resolution, feedback to clinical trial teams regarding quality of data
  • Non-CRF electronic data handling (receiving, archiving, loading into study database, review and resolution of reconciliation issues, feedback to vendors regarding quality of data and other issues)
  • Database edits (paper CRF studies)
  • Manual CRF review (non-medical checks)
  • Clinical database lock
  • Coordination and supervision of processing, dispatch and archiving of CRFs/queries
• Input into design of CRFs and other data collection forms; review Case Report Form design for accuracy and adherence to protocol
• Development of CRF completion guidelines
• Coding medical data with coding dictionaries and coding listings review (Lead DMs with medical/biology background, additional training required)
• SAE reconciliation
•  Electronic data transfer (import/export) specifications review and approval

Document Management

• Liaison with Document Center with regard to maintenance of TMF and eTMF

Quality Control

• Database QC checks performance and documentation
• Shared responsibility for preparation and attendance at internal and client/third-party audits/inspections of Data Management
• Shared responsibility for follow-up on and resolution of audit findings pertaining to Data Management

Training

• Training of Assistant Data Managers
• Project-specific training of investigators and clinical team in CRF completion

Corporate/Departmental Assignments

• Investigator Meetings preparation/attendance
• Meetings and teleconferences organized by client/vendor preparation/attendance

Qualifications

• College or University degree or equivalent combination of training and experience that presents the required knowledge, skills and abilities
• At least 3 years of experience of full scope of data management responsibilities in international EDC studies
• At least 2 years of experience using CDM/EDC systems (Medidata Rave or Oracle Inform preferable)
• Project data management experience is a plus
• Full working proficiency in English
• Organizational and managerial skills

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Job Description

We are looking for a professional, qualified and enthusiastic individual to take up a full-time position of an Administrator, Office Management to support our well established team inMexico.

The ideal candidate will be fast thinking, great at juggling various activities and act as the voice and the face of the company. You will ensure that our clients, colleagues, vendors and visitors feel that they are in good hands. 

Responsibilities: 

• Liaise with vendors, company support services and departments on various matters pertaining to office management and office set-up
• Manage office supplies, equipment and facilities services
• Organize business trips, meetings and events
• Log and sort mail, coordinate shipments
• Provide secretarial support, prepare reports and minutes of meetings
• Assist with photocopying, transcribing and faxing
• Provide administrative help with mobile devices

Qualifications

• Previous administrative experience and experience in an international company is a plus
• Strong communication and organisational skills 
• Problem-solving skills, ability to multi-task, take initiative and act proactively 
• Proficiency in MS Office
• Advanced proficiency in English (C1)

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Job Description

We are currently looking for a knowledgeable and proactive Full-stack Programmer to join our global Data Management team. You will provide the full range of development activities for in-house Data Management department applications, and be involved in something new and challenging.

Please note the official PSI CRO job title will be: Database Developer.

Responsibilities:

• Full-stack development of in-house Data Management department applications (including desktop and simple web applications)
• Perform all development-related activities, including architecting, developing, testing and maintenance 
• Prepare of documentation related to development and maintenance of applications
• Use the internal development standards
• Follow the progress of development technologies and advances professional skills as deemed necessary
• Track the development, maintenance and related tasks in the internal tracking system
• Prepare software development plans, including scoping, scheduling, testing and implementation

Qualifications

• Bachelor's degree in IT or an equivalent combination of education, training and experience
• At least 3 years experience in software development
• Experience in processing user requirements for software development
• Proficiency in SQL
• Ability to develop MS SQL functions, stored procedures, triggers, and other SQL objects
• Experience in generating data queries using Transact SQL
• Knowledge of C#, Microsoft .NET frameworks, technologies, and best practices
• Full working proficiency in English
• Proficiency in building web-based and desktop applications (C#)
• Proficiency in web technologies including JavaScript, HTML5, and CSS
• Knowledge of unit-testing, knowledge of other testing methods is a plus
• Ability to develop design specifications and functional requirements documentation
• Understanding of the entire software development life cycle
• Experience in pharmaceutical industry is a plus

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Job Description

Please submit your CV in English

You will contribute to statistical programming activities related to global clinical trials, work closely with international teams of statisticians, programmers and data managers, program data sets and summaries.

You will:

• Develop analysis data sets structure
• Develop program requirements and specifications
• Be involved in SAS programming of ADS and Tables, Listings and Figures
• Support SAS program validations
• Prepare and review  program documentation
• Produce TFL
• Communicate with project teams and company departments with regard to statistical programming of clinical research projects

Qualifications

• University and master's degree in applied science, mathematics, statistics or the like
• Knowledge of SAS software (SAS BASE/SAS STAT/SAS GRAPH) and experience of work in SAS system
• Good knowledge of programming logic, SQL and macro programming is preferred
• Proficient in English, spoken and written
• Experience within clinical trials and/or Biostatistics
• Good analytical skills
• Proficiency in standard MS Office applications
• Excellent communication and interpersonal skills

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Job Description

Resource Management and Training:

• Participation in QM resource allocation
• Resource allocation of QA auditors
• Facilitation of professional development and career advancement of Quality Management staff
• Administrative supervision of Quality Management staff, jointly with Senior Director Quality Management
• Participation in recruitment of Quality Management (QM) staff
• Facilitation of initial and ongoing training of Quality Management staff
• Oversight of initial and ongoing training of PSI Operations employees in quality management topics

Quality Management:

• Facilitation of regulatory agency inspections of PSI
• Facilitation of regulatory agency inspections of PSI-managed trial sites, including follow-up
• Participation in hosting client/third party audits of PSI, including follow-up
• Oversight of CAPA investigations management
• Management of investigations of suspected research misconduct, jointly with Senior Director Quality Management
• Backup responsibility for review of draft Quality Systems Documents (QSDs), including newly developed and revised QSDs
• Backup responsibility for approval of Quality Systems Documents
• Oversight of vendor qualification
• Oversight of computer systems validation documentation review
• Oversight of the process of providing assistance and feedback to all Company staff with regards to various GXP, regulatory compliance, and other QM matters
• May act as the primary QM contact for PSI Operations divisions and working groups/task forces with regard to various Corporate projects requiring QM

Quality Assurance Auditing:

• Development and implementation of the annual audit plan
• Management of QA audits contracted to PSI
• Oversight of the preparation and maintenance of internal and contracted quality assurance audits documentation

Business Development:

• May be recruited by Business Development for client meetings and vendor shows

Qualifications

• College or university degree
• MD, PharmD or degree in life sciences is a plus
• Minimum 7 years of experience in Clinical Research
• Minimum 5 years of industry experience in the capacity of a QA auditor or equivalent
• Must have experience in planning, conducting and reporting all types of quality assurance audits
• Auditing experience in USA
• Excellent knowledge of ICH GCP guidelines, FDA/ EMA regulations, and applicable local regulations
• Team oriented with superior communication and interpersonal skills 
• Strong time management, organizational, planning and presentation skills
• Demonstrated ability to meet tight deadlines, multi-task/be flexible and thrive in a fast-paced work environment
• Intermediate proficiency in MS Office (Word, Excel Power Point, Outlook)
• Must be a reasonably effective public speaker

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Job Description

We are looking for an experienced CRA ready to train and coordinate junior CRAs on site. Here you will have the opportunity to develop yourself as a trainer, mentor and leader. We are committed to develop our employees in their careers by providing tailored courses and mentoring.

Only CVs in English will be considered
Home-based position in Mexico

You will:

• Conduct and report all types of onsite monitoring visits
• Be involved in study startup (if applicable)
• Perform CRF review, source document verification and query resolution
• Be responsible for site communication and management
• Be a point of contact for in-house support services and vendors
• Communicate with internal project teams regarding study progress
• Participate in feasibility research
• Support regulatory team in preparing documents for study submissions

Qualifications

• College/University degree in Life Sciences or an equivalent combination of education, training & experience
• Independent on-site monitoring experience in Mexico
• Experience in all types of monitoring visits in Phase II and/or III
• Availability to travel
• Experience in Oncology or Infectious Diseases is a plus
• Full working proficiency in English and Spanish
• PC skills to be able to work with MS Word, Excel and PowerPoint
• Ability to plan, deal with different tasks and work in a dynamic team environment
• Communication, collaboration, and problem-solving skills

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Job Description

We are looking for a Quality Assurance Auditor to join us as part of a tight-knit, international team, working across multiple locations and time zones.

You will ensure high quality standards within our clinical trials and internal company processes, and share your expert knowledge with the business. This is an excellent opportunity to work in multiple therapeutic areas and gain exposure to all aspects of the clinical trial process.

This job is home-based in Mexico.

Your responsibilities will include:

• Preparing, conducting, and reporting of QA study audits, internal systems and location audits, vendor qualification audits and maintain relevant communication with the auditee
• Communicating with project teams with regard to QA study audits, including follow-up and resolution
• Assembling QA audits documentation
• Training PSI Operations staff in quality management topics

Please note, this role requires international travel for site audits.

Qualifications

• MD, PharmD or degree in life sciences is a plus
• A minimum of 3 years’ experience in quality management or quality assurance in clinical study environment
• Must have experience in planning, conducting and reporting of QA audits
• Excellent knowledge of ICH GCP guidelines, EMA and FDA regulations, and applicable local laws/regulations
• Team oriented with superior communication and interpersonal skills including a proactive attitude to tasks and projects
• Excellent time management skills
• Demonstrated ability to meet tight deadlines, multi-task/be flexible and thrive in a fast-paced work environment
• Full working proficiency in English
• Proficiency in MS Office applications
• Ability to travel

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Job Description

We are looking for a Quality Assurance Auditor to join us as part of a tight-knit, international team, working across multiple locations and time zones.

You will ensure high quality standards within our clinical trials and internal company processes, and share your expert knowledge with the business. This is an excellent opportunity to work in multiple therapeutic areas and gain exposure to all aspects of the clinical trial process.

This job is home-based in Mexico.

Your responsibilities will include:

• Preparing, conducting, and reporting of QA study audits, internal systems and location audits, vendor qualification audits and maintain relevant communication with the auditee
• Communicating with project teams with regard to QA study audits, including follow-up and resolution
• Assembling QA audits documentation
• Training PSI Operations staff in quality management topics

Please note, this role requires international travel for site audits.

Qualifications

• MD, PharmD or degree in life sciences is a plus
• A minimum of 3 years’ experience in quality management or quality assurance in clinical study environment
• Must have experience in planning, conducting and reporting of QA audits
• Excellent knowledge of ICH GCP guidelines, EMA and FDA regulations, and applicable local laws/regulations
• Team oriented with superior communication and interpersonal skills including a proactive attitude to tasks and projects
• Excellent time management skills
• Demonstrated ability to meet tight deadlines, multi-task/be flexible and thrive in a fast-paced work environment
• Full working proficiency in English
• Proficiency in MS Office applications
• Ability to travel

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Job Description

As a Site Technology Specialist, you will work with clinical sites and provide technical support and expertise related to technology (Kidney imaging, cell therapy, radiology and renal ultrasounds).

Full-time/Perm

You will:

• Provide clinical sites with technical support and expertise related to technology (Nuclear medicine, kidney imaging, interventional radiology)
• Assist in the design and implementation of study related forms, guidelines and manuals related to technologies
• Coordinate data collection related to technologies, including but not limited to nuclear medicine, radiology, etc.
• Provide technical and initiation support to sites
• Identify, track, and report specific technical timepoints in the study related to study procedures including imaging, scans, and other technologies
• Determine technical resources needed for project implementation, and communicates needs to department managers
• Organize technical training for project teams
• Provide support to the project teams to ensure proper documentation of study-specific assessments related to study technologies
• Support site initiation preparation and performs technical visits to assist the site team with technical aspects of the study
• Assist and advises the site monitor in the area of study technologies
• Provide relevant technology-related information to Business Development for proposals
• Prepare for and attends Bid Defense Meetings
• Attend and presents at Investigator’s Meetings

Qualifications

• BSRT, RN, LPN, and/or equivalent degree 
• Licensed specialist in relevant technology; CNMT required (Certified Nuclear Medicine Technologist).
• Minimum 5 years’ experience in the specified technology: Nuclear Medicine, Molecular imaging, etc. 
• Experience in operation and QC procedures related to overseeing and managing PET imaging agents and therapeutic RLTs
• Proficiency in standard MS Office applications
• Must have the ability to travel (20% of time)
• Must have excellent communication skills and the ability to collaborate while working in a team environment

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