3 weeks ago

Trial Committee Manager

PSI CRO

Amsterdam

3 weeks ago

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PSI, a global Contract Research Organization, seeks a Trial Committee Manager to oversee the end-to-end management of clinical trial committees (IDMC, Safety Review Committee, Adjudication Committee). The role involves coordinating committee activities, developing documentation, and engaging external experts, requiring a Bachelor's degree and at least 3 years of clinical research experience.

On-siteFull-timeMid LevelClinical ResearchProject Management

Trial Committee Manager

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On-siteFull-timeMid LevelClinical Research

Salary

Not specified

Work Location

Amsterdam, North Holland, Netherlands, NL

Work Model

On-site

Experience Required

3 years

Employment Type

Full-time

Experience Level

Mid-Senior level

Core Qualifications

Technical (Must-have)

Clinical ResearchProject ManagementStakeholder CoordinationMicrosoft OfficeVirtual Meeting PlatformsCommittee ManagementDocumentationQuality AssuranceCommunicationProblem SolvingAttention to Detail

Soft Skills

CommunicationProblem SolvingOrganizational SkillsAttention to DetailStakeholder Management

Key Responsibilities

•Managing the full lifecycle of clinical trial committees, from committee setup and member selection through study conduct and close-out.
•Coordinating committee meetings, communications, recommendations, and follow-up activities throughout the course of clinical trials.
•Developing, maintaining, and updating committee charters, procedures, and other trial-specific documentation.
•Identifying, evaluating, and engaging qualified external committee members based on study requirements, expertise, availability, and independence criteria.
•Performing Fair Market Value assessments and preparing honorarium estimates for independent committee members.
•Supporting audits and inspections related to committee management activities and contributing to corrective and preventive actions, as needed.
•Contributing to the development and continuous improvement of committee-related quality documentation, business processes, templates, and training materials.
•Supporting the planning and delivery of internal training on committee management processes.

Clinical ResearchTrial Committee ManagementCROPharmaceuticalFull-timeOn-siteAmsterdamProject ManagementStakeholder Coordination

Core Qualifications

Technical (Must-have)

Clinical ResearchProject ManagementStakeholder CoordinationMicrosoft OfficeVirtual Meeting PlatformsCommittee ManagementDocumentationQuality AssuranceCommunicationProblem SolvingAttention to Detail

Soft Skills

CommunicationProblem SolvingOrganizational SkillsAttention to DetailStakeholder Management

Key Responsibilities

•Managing the full lifecycle of clinical trial committees, from committee setup and member selection through study conduct and close-out.

•Coordinating committee meetings, communications, recommendations, and follow-up activities throughout the course of clinical trials.

•Developing, maintaining, and updating committee charters, procedures, and other trial-specific documentation.

•Identifying, evaluating, and engaging qualified external committee members based on study requirements, expertise, availability, and independence criteria.

•Performing Fair Market Value assessments and preparing honorarium estimates for independent committee members.

•Supporting audits and inspections related to committee management activities and contributing to corrective and preventive actions, as needed.

•Contributing to the development and continuous improvement of committee-related quality documentation, business processes, templates, and training materials.

•Supporting the planning and delivery of internal training on committee management processes.