Clinical Lead Cra M - F H/F GI Life Sciences
Gif-sur-Yvette - 91 CDDOffre d’une agence de travail temporaire
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Cette offre est publiée par une agence de travail temporaire. Il ne s'agit pas de l'entreprise dans laquelle vous travaillerez au quotidien.
- Bac +5
- Industrie Pharmaceutique • Biotechn. • Chimie
- Exp. - 1 an
Les missions du poste
We are recruiting in Ulis for a Clinical Project Manager (M/F) for a 6-month mission (potentially renewable) within a prestigious pharmaceutical group starting in May 2025. Our client is a company focused on the research and development of new pharmaceutical products and/or new processes in the field of plasma derivatives and biotechnology.
As a Clinical Lead CRA (M/F), you will contribute at the international level by coordinating, overseeing, and reporting on local Clinical Operations (monitoring and local study management) to ensure that study-related activities are conducted according to expected quality, timelines, and budget. You will execute in-house study operations tasks and oversight as delegated by the Study Team Leader.
Main responsabilities
* The role involves acting as a liaison for field activities across various countries participating in clinical trials, ensuring effective communication and information dissemination among international study personnel and the Study Team. At the international level, the individual coordinates and oversees local/regional Clinical Operations Project Managers (COPMs) to ensure that study-related activities meet quality standards, timelines, and budget constraints.
* Key responsibilities include participating in the creation of study budgets, training local teams on budget drivers and estimations, and managing the local study budget in collaboration with COPMs. The individual actively engages in Study Team meetings, providing concise updates on study progress from a clinical operations perspective, identifying critical field operations issues, proposing solutions, and updating the team on central vendor activities.
* Training is a significant aspect of the role, as the individual ensures that international Clinical Operations personnel are adequately trained on the study in a timely manner. This includes organizing and participating in Investigator meetings and other study-related gatherings. The individual leads the execution of country and center feasibility analyses, consolidating feedback to propose various scenarios to the Study Team.
* Collaboration with the Study Team Lead is essential for identifying appropriate monitoring strategies and developing the Monitoring Plan, incorporating input from local COPMs for both in-house and outsourced monitoring. The individual also defines patient recruitment strategies for the clinical trial in conjunction with the Study Team.
* Responsibilities extend to the creation, review, and updating of key study documentation, overseeing subject recruitment and retention, and proactively working with COPMs to develop action plans when necessary. The individual detects trends in study quality issues, conducts root cause analyses, and follows up on corrective and preventive actions, reporting significant issues to the Study Team as needed.
* Additionally, the role involves contributing to the selection and management of Full-Service CROs and central vendors, overseeing the preparation and deployment of study materials and logistics, and ensuring that all necessary study documentation is gathered and filed in the Trial Master File in a timely manner. The individual also participates in process definition, optimization, and SOP development related to Clinical Operations processes, while organizing and managing the agenda and minutes for Investigator meetings and other study-related meetings. Finally, the individual handles tasks as delegated by the Study Team Lead.
Profil
* Pharmacist or engineer with a degree in science or equivalent and at least 5 years of clinical operations experience.
* Strong project management, leadership, and organizational skills.
* Excellent interpersonal and communication abilities for relationship building.
* Experience managing third-party vendors (CROs) and identifying risks.
* Capable of working under pressure and managing multiple tasks.
* Proficient in English and willing to travel.
Le profil recherché
* Pharmacist, engineer (linked to health science), degree in science or equivalent with least 5 years of experience in clinical operations field.
* Proven successful project management & leadership skills and a very strong organizational and planning management skills (including management at distance).
* Strong interpersonal and communication skills, including the ability to develop and maintain strong relationships within the Study Team and international study personnel.
* Proven experience managing and overseeing third-party vendors (CROs).
* Strong capability to proactively identify risks and apply problem-solving skills.
* Ability to work well under pressure, manage multiple tasks in a dynamic environment with shifting priorities.
* Excellent knowledge of English (writing and speaking).
* Willingness and ability to travel.
L'entreprise
We are recruiting in Ulis for a Clinical Project Manager (M/F) for a 6-month mission (potentially renewable) within a prestigious pharmaceutical group starting in May 2025.
Gi Group Consulting is an international consulting group with a revenue of €2.84 million and a growth rate of 25%. As a family-owned company specializing in placing our talents within the healthcare industry, we place Human values at the core of our mission. We dedicate our expertise in Life Sciences to our clients : pharmaceutical groups, CROs, and Biotech companies.
- Gif-sur-Yvette - 91
- CDD
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