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