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 business specializing in the placement of talent 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 Saclay for a Clinical Lead CRA (Clinical Research Associate) (M/F) for a mission within a prestigious pharmaceutical group starting in March 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 actively coordinate, oversee, and report on the local Clinical Operations (monitoring and local study management) to ensure that study-related activities are conducted according to the expected quality, timelines, and budget. You will also 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 different countries, consolidating and disseminating relevant information to the Study Team.


• Coordinates and oversees local/regional Clinical Operations Project Managers (COPMs) to ensure study activities meet quality, timelines, and budget.


• Participates in study budget creation and trains local teams on budget management, collaborating with COPMs on local budget reporting.


• Provides updates on study progress in Team meetings, identifies operational issues, and proposes solutions.


• Ensures timely training of international Clinical Operations personnel and organizes Investigator meetings.


• Leads feasibility analyses for countries and centers, proposing scenarios to the Study Team.


• Develops the Monitoring Plan with input from local COPMs and defines patient recruitment strategies.


• Responsible for creating, reviewing, and updating key study documentation.


• Oversees subject recruitment and retention, proposing action plans as needed.


• Identifies study quality issues, conducts root cause analysis, and follows up on corrective actions.


• Contributes to the selection and management of CROs and central vendors.


• Oversees the preparation and logistics for study materials.


• Ensures timely filing of study documentation in the Trial Master File.


• Participates in process optimization and SOP development for Clinical Operations.


• Organizes Investigator meetings, managing agendas and minutes.


• Handles additional tasks as delegated by the Study Team Leader.

Profile                                                                                                                                                           

• Pharmacist, engineer, degree in science or equivalent.


• At least 5 years of experience in clinical operations field with proven successful project management & leadership skills.


• Very strong organizational and planning management skills (including management at distance).


• Strong interpersonal and communication skills.


• 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.

Location : Saclay

Start : ASAP

Benefits of Gi Group Consulting: meal vouchers, performance bonus, profit-sharing, and advantageous employee benefits.

Lieu de la mission