20 beste vacatures voor de functie van clinical project in leuven, vlg (nieuwe medewerkers gezocht)

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Trial Committee Manager

PSI CRO -
Leuven

Snel solliciteren

Vacaturegegevens

Voltijds
11 dagen geleden

Extralegale voordelen

Bedrijfsopleidingen

Kwalificaties

Onderzoek
Microsoft Office
Projectmanagement

Volledige vacaturetekst

Company Description

PSI is a global Contract Research Organization (CRO) with over 30 years of experience supporting clinical research around the world. We combine the stability of an established organization with the agility and innovation needed to advance modern clinical trials. Guided by a commitment to quality and on-time delivery, we partner with clients across a broad range of therapeutic areas while providing our employees with an environment where they can grow, contribute, and make a meaningful impact on global healthcare.

Job Description

The Trial Committee Manager oversees the end-to-end management of clinical trial committees (IDMC, Safety Review Committee, Adjudication Committee etc.) that provide unbiased oversight and expert guidance throughout the lifecycle of clinical trials. In this role, you will serve as the central point of coordination for sponsors, committee members, and cross-functional PSI teams, ensuring committee activities are executed efficiently, compliantly, and to the highest quality standards. You will collaborate with global project teams and external experts to support the successful delivery of clinical trials across a variety of therapeutic areas.

You will be responsible for:

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.

Qualifications

Bachelor's degree in Life Sciences, Pharmacy, Healthcare, Clinical Research, or a related field.
At least 3 years of experience in clinical research, preferably within a CRO environment.
Experience managing or coordinating clinical trial committees or comparable experience in clinical trial management with exposure to committee processes.
Proven project management and stakeholder coordination skills, with the ability to manage multiple priorities in a fast-paced environment.
Strong organizational, communication, and problem-solving skills with exceptional attention to detail.
Ability to build effective working relationships with sponsors, external experts, and cross-functional teams.
Professional proficiency in English (written and spoken).
Proficiency in Microsoft Office applications and virtual meeting platforms.

Additional Information

Join a collaborative, globally connected team dedicated to ensuring the highest standards of independent clinical trial oversight. In this role, you'll work closely with sponsors, renowned external experts, and cross-functional teams to facilitate unbiased committee governance that supports critical decisions throughout the clinical trial lifecycle.

If you're passionate about clinical research, thrive in a highly organized, stakeholder-facing environment, and enjoy coordinating complex projects that make a real impact on the quality of clinical trials, we'd love to hear from you.

Snel solliciteren

Verfijn je zoekopdracht

clinical project vacatures in leuven, vlg

Trial Committee Manager

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Clinical Trial Supply Manager – Brussels, Belgium (F/M)

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Regulatory and Start Up Specialist - Belgium

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