Do you have clinical project management experience and are you up for a new challenge in one of the best Pharmaceutical companies in the world? Don't hesitate and apply today !
Job Description
The Clinical Project Manager provides leadership and regional/local strategic planning and operational delivery of assigned clinical studies through all phases of study management (preparation, study start-up, conduct, close-out), in accordance with quality standards, all applicable regulations, timelines and budget commitments.
For Global/Regional Studies (referred as Global), the Clinical Project Manager leads and has full accountability (time, quality, cost) in alignment with the Study Management Team (SMT).
For Local Studies, the Clinical Project Manager acts as study leader and, in addition to the above, provides the leadership and clinical operational expertise for the local study team.
Responsibilities
- The Clinical Project Manager has full accountability and oversight for all assigned studies at regional/country level (Global and local studies) in accordance with the overall project plan, manages and maintains accurate country /study level plans (e.g. timelines, budget, resource, risk and quality plans) in the appropriate planning system.
- The Clinical Project Manager highlights deviations and risks in plans to relevant parties, develops and implements mitigation strategies as required.
- The Clinical Project Manager leads local study teams, represents Country /Region Clinical Operations at the global SMT, and provides Global teams with feedback From an Affiliate perspective (Global).
- The Clinical Project Manager plans and executes country study goals and commitments, and ensures compliance to relevant processes.
- The Clinical Project Manager may serve as global Country Study Representative (gCSR), as part of global study team.
- The Clinical Project Manager coaches and provides support to responsible study team members.
- The Clinical Project Manager provides study oversight, leadership and support to Contract Research Organization (CRO) staff to ensure overall delivery at the country and site level, and interfaces with CRO Management regarding feedback on CRO staff performance as required.
- The Clinical Project Manager 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.
- The Clinical Project Manager 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.
- The Clinical Project Manager develops and maintains optimal site relationships with key investigator sites, alliance partners and/or collaborative group for current and future studies.
- The Clinical Project Manager participates in overall Therapeutic Area support together with the therapeutic leads and country experts (e.g.landscaping activities, investigator/site development activities or affiliate cross functional teams, etc.), as required.
Requirements
- You hold a University degree, minimum Master in Science
- You have minimum 5 years Clinical Trials experience
- You have extensive experience in clinical project management
- Experience with Phase 1 or rare diseases is a big plus
- You are bilingual in French & Dutch, very good level of English (written and spoken)
- You have good knowledge of Microsoft Office (Powerpoint, Excel, etc…)
- You are good at coaching
- You have strong decision making skills
- Being a team player and being flexible to take on other tasks is very important in this environment
- You are a strong communicator
- You have an open mindset
- You are innovative
- You are excellent in planning and organizing
- Existing right to work in Europe required
Benefits
- A fulltime position with a permanent contract as a consultant via Oxford
- A balanced salary package based on your experience and fringe benefits (company car, fuel card, insurances, 12 ADV, ...)
- You will be able to work in one of the biggest pharma companies in Belgium
- You will enter an environment where a good work-life balance is very important
Vacancy number: 18435
