Clinical Project Manager
Clinical Project Manager
Our client is a biotechnology company located in Liège areas.
The International Clinical Project Manager manage all activities within Clinical Operations related to one or more clinical trial(s) including clinical study timelines, budget, and quality from Study synopsis until Clinical Study Report. He/She coordinates and leads the activities of different Study Team members.
Reports directly to the Chief Medical Officer.
- Responsible for the operational aspects during the planning, start-up, conduct and close-out phase of the given trial(s) while ensuring the quality and the integrity if the date (e.g in line with GCP/ICH guidelines) and adhering to the agreed project timelines and budget.
- First point of contact for Clinical Operations-related questions for the given trial(s).
- Provide regular updates on trial evolution to the project teams and manager and escalate any significant issues which may have an immediate impact on patient safety or conduct of the study, timelines, budget, and/or data quality.
- Contribute to timely development and/or review of trial-specific documentation (e.g, protocol, protocol amendments, risk management plan, trial-related vendor documents…)
- Ensure the timely selection and qualification of CRO’s and vendors, their training and management throughout the study.
- Organize kick-off meetings, investigators meeting and managing the CRO’s output and responsibilities.
- Operational implementation of trial protocol, including coordination of trial-related activities with both internal (medical, regulatory, …) and external (CRO, central/referral labs) parties.
- Work in close relation with Clinical Trial Assistant(s).
- Contribute in process improvement activities within Clinical Operations.
Skills and experience
- At least 5 years of experience with international clinical operations in Pharma, Biotech or CRO (phase 3 experience is a must, in respiratory diseases an asset).
- A medical or paramedical (e.g pharmacy, biology, veterinary) degree.
- Excellent knowledge of ICH, European directives and FDA guidelines related to GCP, experienced with adhering to SOP’s and guidelines regarding the conduct of clinical trials.
- Team player.
- Project management and organizational skills.
- Good communication skills.
- Flexible, conflict handling and problem solving skills, sense of innovation.
- Being accountable: exercising judgement/impact of decisions/consequence of error.
- Able to manage multiple and varied tasks and prioritize workload with attention to detail.
- Good knowledge of written and spoken English.
- Knowledge of an experience with basic computer programs: experience with MS Project is an asset.
- Is willing and capable to go the extra mile if needed.
Keywords : clinical, project, manager, biotech.
Our client offers you a challenging position in his company. You will receive an attractive salary package.
Interested ? Contact me at 02 379 11 76 or firstname.lastname@example.org.