Medical Affairs Project Manager
6 days ago
Job Description
The Senior Clinical Project Manager will collaborate with cross-functional teams, including Medical and Scientific Affairs, Clinical Affairs, and Global Clinical Affairs, to manage and complete studies in compliance with regulations like Good Clinical Practices (GCP), IVDR, and GDPR.
Main Responsibilities:- Leading and overseeing clinical performance evaluation studies for BD devices in Europe.
- Preparing and reviewing essential study documents and managing budgets, timelines, and resources.
- Identifying suitable clinical sites and managing training materials.
- Ensuring the study trial master file is complete and addressing risks that could compromise the study.
About You
Education and Experience:
- Advanced degree in a relevant scientific discipline or master's degree in Biological Sciences or Biomedical engineering focused on Biotechnology.
- Minimum of 6 years of relevant industry experience in product development or a combination of equivalent education and experience.
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