For a client located in Liege region, we are seeking an experimented :
International Clinical Project Manager
- Do you have a medical or paramedical (e.g. pharmacy, biology, veterinary) degree?
- Can you prove at least 5 years of experience in international clinical operations (Phase 3) in Pharma, Biotech or CRO?
Then this might be the opportunity you are looking for!
The position is opened to Freelancers .
Read more and apply as soon as you can!
As International Clinical Project Manager you manage all activities within Clinical Operations related to 1 or more clinical trial(s), including clinical study timelines, budget, and quality from Study synopsis until Clinical Study Report.
You coordinate and lead the activities of different Study Team members
Main responsibilities / Major Activities
- You are 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 of the data (e.g. in line with GCP/ICH guidelines) and adhering to the agreed project timelines and budget.
- You act as first point of contact for Clinical Operations-related questions for the given trial(s).
- You 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.
- You contribute to timely development and/or review of trial-specific documentation (e.g., Protocol, Protocol amendments, Risk Management Plan , trial-related vendor documents…).
- You ensure the timely selection and qualification of CRO’s and vendors, their training and management throughout the study.
- You organize Kick-off Meetings, Investigators meeting and manage the CRO’s output and responsibilities.
- You are responsible for the operational implementation of trial protocol, including coordination of trial-related activities with both internal (medical, regulatory, …) and external (CRO, central/referral labs) parties.
- You are potential line manager of Clinical Trial Assistant(s).
- You contribute in process improvement activities within Clinical Operations
- You have at least 5 years experience with international clinical operations in Pharma, Biotech or CRO (Phase 3 experience is a must, in respiratory diseases an asset).
- You have a medical or paramedical (e.g. pharmacy, biology, veterinary) degree.
- You have excellent knowledge of ICH, European directives and FDA guidelines related to GCP, you are experienced with adhering to SOPs and guidelines regarding the conduct of clinical trials
- You are Team Player.
- You posses Project Management and organizational skills.
- You have good Communication skills.
- You are flexible, and have conflict handling and problem-solving skills, sense of innovation.
- You are accountable: exercising judgement/impact of decisions/consequence of error.
- You are able to manage multiple and varied tasks and prioritize workload with attention to detail.
- You have good knowledge of written and spoken English.
- You have knowledge of and experience with basic computer programs; experience with MS Project is an asset.
- You are willing and capable to go the extra mile if needed