- Provide medical and scientific support to company research teams: protocol design, CRF content, adverse events follow up and analysis, discussions and guidance towards investigators, internal meetings, etc.
- Provide support to clients for clinical activities such as global medical oversight of clinical trials, participation to study setup, supervision of PV activities, review of clinical study reports, writing of regulatory documents.
- Participate in clinical protocol writing, protocol review
- Supports or represents sponsor companies at various meetings (Investigator meeting, Study Initiation Visits …) regarding the medical and operational aspects of clinical phase programs.
- Due diligence activities, review and analyze documents including, Investigator Brochure, clinical study reports, feedback from Regulatory Agencies, scientific literature etc.
- Qualification: Medical Doctor.
- Experience: At least 3 years of experience in the area of clinical research (pharmaceutical company or CRO).