Clinical Trial Manager - Belgium
DRIVE clinical studies: Interventional and Non-Interventional (Retrospective and Prospective studies)
- Manage the successful planning, set-up and follow-up of the support given to the Third Party Investigator
- Ensure proper documentation and proper regulation applicable to each Third Party Study
- Draw up contracts in collaboration with the Medical Scientific Liaison, the Drug Monitoring department, the regulatory affairs and the legal department
- Ensure proper collection and validation of data on a timely manner
- Organize study specific meetings; Collect, synthesize and report study information
- Participate in the development/follow-up of the study budget
- Preparation and oversight of study audits
Education : Master degree or PhD in Sciences with ability to independently research questions; scientific background required to critically evaluate all scientific aspects of studies.
Experience : Minimum 4 years experience in clinical trial management.
- Proven expertise in clinical research with international Good Clinical Practice Guidelines, basic knowledge of human experimentation laws and regulations.
- Basic technical writing and teaching skills; good stage presence for public speaking.
- Basic capability to manage people and budget
- Starting level of leadership of small teams under stress.
- Strong technical, statistical and computer skills and the ability to interpret complex clinical data and experimental results.
- Ability to develop network internally and externally to communicate in situations requiring special tact and diplmomacy