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Clinical Trial Operations Director
2 weeks ago
Job Summary
The Senior Clinical Project Manager will lead and oversee clinical performance evaluation studies for BD devices in Europe. This role involves collaborating with cross-functional teams, including Medical and Scientific Affairs, Clinical Affairs, and Global Clinical Affairs, to manage and complete studies in compliance with regulations.
Key Responsibilities:- Managing complex clinical evaluations, preparing and reviewing essential study documents, and overseeing relationships with CROs, vendors, and clinical sites.
- Identifying suitable clinical sites, managing training materials, and ensuring the study trial master file is complete.
- Addressing risks that could compromise the study and communicating effectively with internal and external partners and stakeholders.
About The Role
This role serves as the project lead for moderate to high complexity studies from protocol development through study conduct and closeout in compliance with Good Clinical Practices and all Global, National and Local Regulations.