International Clinical Operations Lead H/F
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,
estimations and assumptions. In collaboration with the COPMs, develops, manages and reports
- n 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.
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 Leader, 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 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
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
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
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
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
Job tags
Salary