Clinical Project Manager (CPM)
For a leading pharmaceutical company, we are looking for a Clinical Project Manager (CPM) to provide leadership, strategic planning and operational delivery of assigned global and local clinical studies through all phases of study management.
For Global/Regional Studies, the CPM leads and has full accountability (time, quality, cost) in alignment with the Study Management Team (SMT)
For Local Studies, the CPM acts as study leader and, in addition to the above, provides the leadership and clinical operational expertise for the local study team.
TASKS / RESPONSIBILITIES
- Has full accountability and oversight for all assigned studies at regional/country level, in accordance with the overall project plan, manages and maintains accurate country /study level plans.
- Highlights deviations and risks in plans to relevant parties, develops and implements mitigation strategies as required.
- Leads local study teams, represents Country /Region Clinical Operations at the global SMT, and provides Global teams with feedback From an Affiliate perspective.
- Plans and executes country study goals and commitments and ensures compliance to relevant processes.
- May serve as global Country Study Representative (gCSR), as part of global study team.
- Coaches and provides support to responsible study team members.
- Provides study oversight, leadership and support to CRO staff to ensure overall delivery at the country and site level.
- Oversees study feasibility, site monitoring performance, preparation of Risk Based Monitoring plans, and ensures eTMF completeness and oversight of all relevant compliance activities for allocated studies.
- Collaborates in local quality/compliance reviews, internal audits, and regulatory inspections, ensuring inspection readiness at all times and completion of Corrective and Preventative Actions for allocated studies.
- Develops and maintains optimal site relationships with key investigator sites, alliance partners and/or collaborative group for current and future studies.
- Participates in overall Therapeutic Area support together with the therapeutic leads and country experts as required.
- Minimum Master’s degree; preferably in a medical/science-related field.
- Experience: Minimum 6 years in clinical trials
- Based in Belgium.
- Fluent in English, written and spoken. FR and/or NL is an asset.
- Good knowledge of Pack Microsoft Office
- Identifies and understands problems and opportunities by gathering, analysing, and interpreting quantitative and qualitative information.
- Establishes an action plan for self and others to complete work efficiently and on time by setting priorities, establishing timelines, and leveraging resources.
- Conveys information and ideas clearly and concisely to individuals or groups in an engaging manner.
- Listens actively to others