Responsable Clinique CRA (H/F)

Description du poste et des missions

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.

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.

Principales responsabilités / attendus du poste

• Acts as a liaison between field activities in the different countries participating in clinical trials, consolidating, analyzing and disseminating any relevant information to international study personnel and the Study Team.


• At the international level, coordinates, oversees and reports on the local/regional Clinical Operations Project Managers (COPMs) to ensure that study-related activities are conducted according to expected quality, timelines and budget.


• Actively participates in the study budget creation, train local teams on the budget drivers, estimations and assumptions. In collaboration with the COPMs, develops, manages and reports on the local study budget (external and internal costs).


• Actively participates in Study Team meetings, providing up-to-date and concise information on study progress from the clinical operations perspective, identifying important field operations issues that require input from the Team, proposing solutions and providing also updates on central vendors activities as relevant.


• Ensures that the international Clinical Operations personnel are adequately trained on the study and in a timely manner. Provides training in operational aspects to personnel as required. Organizes and participates actively to the Investigator meetings and any other study-related meetings as needed.


• Leads the execution of the country and center feasibility and analyses and consolidates the results/feedback to the Study Team. As result of this process, he/she proposes different scenarios to the study team.


• In collaboration with the Study Team Lead, identifies an appropriate monitoring strategy, then develops the Monitoring Plan with input from the local COPMs, both for in-house and outsourced monitoring choices.


• In collaboration with Study team lead and study team actors, she /he defines the patient in strategies for the clinical trial.


• Responsible of the creation/ review and update of key study documentation.


• Oversees subject recruitment and retention during the study and, when necessary, pro-actively works with COPMs to develop and propose action plans to the Study Team.


• Detects study quality issues trends, root cause analysis & follow-up corrective and preventive actions as necessary (protocol deviations, CAPA plans escalated by local teams, participation in Data Review and Surveillance meetings) and when relevant, reports important issues to the Study Team.


• Contributes to the selection, management and oversight as applicable  of Full service CROs / central vendors (central lab, central reading, Patient services…).


• Be responsible for  the oversight of the preparation and deployment of materials, tools and logistics for the study.


• During the course of the study, ensures that all necessary study documentation is gathered and correctly filed  on a timely basis  in the study Trial Master File.


• Participates in process definition and optimisation and SOP development efforts with regard to Clinical Operations processes.


• Organizes and participates actively to the Investigator meetings and any other study-related meetings as needed, being also responsible for the agenda and the minutes.


• Handles any tasks as delegated by the STL.

Profil

• 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.

Do you want to join a dynamic and ambitious group?

Does the position match your expectations and skills?

Don't hesitate any longer and apply!

Lieu de la mission