Location
Les Ulis, Essonne | France
Job description
At the international level, coordinates, oversees and reports on the local Clinical Operations (monitoring and local study management) to ensure that study-related activities are conducted according to expected quality, timelines and budget. Executes in-house study operations tasks and oversight as delegated by Study Team Leader (STL).
Activities and responsibilities
- Acts as a liaison between field activities in the different countries participating in clinical trials,
personnel and the Study Team
- At the international level, coordinates, oversees and reports on the local/regional Clinical
according to expected quality, timelines and budget
- Actively participates in the study budget creation, train local teams on the budget drivers,
central vendors activities as relevant
- Ensures that the international Clinical Operations personnel are adequately trained on the study
meetings as needed
- Leads the execution of the country and center feasibility and analyses and consolidates the
to the study team
- In collaboration with the Study Team Leader, identifies an appropriate monitoring strategy, then
monitoring choices
- In collaboration with Study team leader 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
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
Clinical Operations processes
- Organizes and participates actively to the Investigator meetings and any other study-related
Profile
- Pharmacist, engineer, degree in science or equivalent
- At least 5 years of experience in clinical operations field
- Proven successful project management & leadership skills
- Very strong organizational and planning management skills (including management at distance)
- Strong interpersonal and communication skills, including the ability to develop and maintain
shifting priorities
- Excellent knowledge of English (writing and speaking)
- Willingness and ability to travel
Job tags
Salary
