Job Description
As Clinical Project Manager, you will have several responsibilities.
Responsibilities
- You are in charge of the Management and coordination of clinical trials (phase II and III)
- You participate to study design and protocol development
- You are responsible for the Scientific and medical writing - study related documents: protocols, IB, ICF, CRF, ...
- You are responsible for the preparation of regulatory documents/submission files to EC (CA)
- You are responsible to manage Site Relationship: investigators, site selection, initiation visits, investigator agreement preparation, organization of investigator/meetings
- You manage CRO and monitoring activities
- You review clinical trials data and will support in the preparation of clinical study reports
- You contribute to Safety Management: reporting, notification of safety events – follow up and safety report preparation
- You are responsible for the development of credible relationships with KoL, Investigators, and key stakeholders
- You review medical literature and related new technologies in close collaboration with other departments (preclinical, regulatory, production, QC, IP…)
- You have an advanced scientific degree (PhD, MD)
- You have at least 2-4 years of experience as Clinical Project Manager and 1-2 years of experience in Study Monitoring (as a CRA), preferably in phase II and III trials
- You are fluent in English
- You have a strong knowledge of ICH-GCP principles
- You are autonomous and a real team player
- You have strong interpersonal and communication skills
- You are able to work within Start up and Biotech environment in a quickly growing structure
- You are reactive to deadlines, pro-active, dynamic and problem solving