For one of our clients located in the Hainaut, we are urgently looking for an experienced Clinical Project Manager, available for a 6 months assignment, starting from April 1st at the latest.
As Clinical Project Manager, you have several responsibilities.
- Management and coordination of phase II and III clinical studies.
- Participation to study design and protocol development
- Scientific and medical writing: study related documents (protocols, IB, ICF, CRF, …)
- Preparation of regulatory documents/submission files to EC (CA)
- Management of relationship with sites: investigators, site selection, initiation visits, investigator agreement preparation, organization of investigator/meetings
- CROs management and monitoring activities management
- Review of clinical trial data, support in preparation of clinical study reports
- Contribution to Safety Management: reporting, notification of safety events, follow up and safety report preparation
- Development of credible relationships with KoL, Investigators, and key stakeholders;
- Review of medical literature and related new technologies, and working in close collaboration with other departments (preclinical, regulatory, production, QC, IP…)
- You have a Scientific degree (Master, PhD or MD)
- You have at least 2 years of experience as Clinical Project Manager and 1-2 years of experience in study monitoring as a CRA within a pharma industry or biotech environment
- You have a strong knowledge of ICH-GCP requirements
- You are fluent in English and in French. Knowledge of Dutch is an asset.
- You are autonomous, a real team player and you have strong interpersonal and communication skills
- You are reactive to deadlines, pro-active, dynamic and problem solving