Becton Dickinson and Company Sr. Clinical Project Manager
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Job Description Summary:
The Senior Clinical Project Manager will lead clinical performance evaluation studies for BD devices in Europe, focusing on the procurement of human bio-specimens for analytical and clinical studies. This role involves collaborating with cross-functional teams to manage and complete studies in compliance with regulations like Good Clinical Practices (GCP), IVDR, and GDPR.
About the Role
* Manage complex clinical evaluations, prepare and review essential study documents, and oversee relationships with Contract Research Organizations (CROs), vendors, and clinical sites.
* Manage budgets, timelines, and resources, ensuring studies are executed on schedule and within budget.
* Identify suitable clinical sites, manage training materials, ensure the study trial master file is complete, and address risks.
Key Responsibilities
1. Collaborate with cross-functional teams, including Medical and Scientific Affairs, Clinical Affairs, and Global Clinical Affairs.
2. Mentor less experienced team members and provide regular communication with internal and external stakeholders.
Requirements
* Advanced degree in a relevant scientific discipline (PhD, MD), or a master's degree (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, preferably with in-vitro diagnostics.
Desirable Skills
* Result and detail-oriented, self-motivated with ability to take risks, willing to learn, experience with literature research methods and databases preferred.
* Working knowledge of MS Office, strong skills with MS Excel, EndNote, Pubmed, Medline, and/or database development.