The CPL is a member of the Project Team and has overall responsibility and accountability for the execution of the clinical operations strategy of the project on a regional or global level, as assigned. The CPL is responsible for coordinating and managing the clinical operations and local site services maintenance team, providing leadership and expertise to ensure successful execution of the site selection, clinical operations and IRB/IEC/regulatory maintenance project deliverables (quality, timeline, budget and scope).
This role requires collaboration within a matrix environment, proactive internal/external communication, and exceptional strategic planning, risk management and organizational skills.
As a Clinical Project Lead your main responsibilities will be:
- The Clinical Project Leader (CPL) is responsible for the set up and progress of a clinical trial/study within the allocated countries, ensuring compliance with company quality standards and regulations in force, the forecasted timelines, milestones and budget.
- The CPL represents the countries in his/her perimeter at the global Clinical Trial Team (CTT) and is the main contact for the Regional Trial Manager (RTM) and global CTOM.
- He/she ensures liaison with other CTT members (CSD, SDM, TSOM…).
- He/she leads the monitoring teams in the designated countries for his/her trials
- He/she represents the CSU at Medical Affairs/Business Unit meetings to feedback on study progress
- Is accountable for set-up activities according to the company standards, regulations in force and country generic administrative timelines (submission to ECs/IRBs/HAs, approvals, contracts with sites, local AEDs), and that committed targets and timelines are met at all steps and until study completion (recruitment, active/inactive sites, deadlines for DMCs, DBL, closure of sites, archiving).
- Is the first point of contact for Regional Trial Managers (RTM), other global CTT members and the local monitoring teams.
- Is the first point of contact for Medical Affairs/Business Units for locally initiated studies, providing input to feasibility, study design and budget development and providing feedback on study progress.
- Organizes kick-off meeting with local monitoring teams (MT).
- Organizes training of monitoring teams (study procedures, study devices, monitoring plan,…).
- Organizes investigators meetings.
- Provides support to MT (protocol, monitoring plan, CRF, tools…)
- Prepares or arranges the preparation of protocols, written subject information, other essential documents, CSR, etc. for studies initiated locally