logo

JobNob

Your Career. Our Passion.

International Clinical Operations Lead H/F


Joblift


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

personnel and the Study Team

according to expected quality, timelines and budget

estimations and assumptions. In collaboration with the COPMs, develops, manages and reports

study progress from the clinical operations perspective, identifying important field operations

central vendors activities as relevant

and in a timely manner. Provides training in operational aspects to personnel as required.

meetings as needed

results/feedback to the Study Team. As result of this process, he/she proposes different scenarios

to the study team

develops the Monitoring Plan with input from the local COPMs, both for in-house and outsourced

monitoring choices

strategies for the clinical trial

works with COPMs to develop and propose action plans to the Study Team

actions as necessary (protocol deviations, CAPA plans escalated by local teams, participation in

Team

central vendors (central lab, central reading, Patient services..

logistics for the study

correctly filed on a timely basis in the study Trial Master File

Clinical Operations processes

meetings as needed, being also responsible for the agenda and the minutes

Profile

strong relationships within the Study Team and international study personnel

- 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


Job tags

Emploi intérim


Salary

All rights reserved