Vacancy Description
Responsibilities
- Act as the main point of contact and support for the assigned investigational sites.
- Prepare, conduct, and report remote and onsite monitoring visits in accordance with the Monitoring Plan and applicable SOPs.
- Assess investigational site performance and ensure compliance with study protocol, GCP, and regulatory requirements.
- Perform all required activities during monitoring visits according to internal and/or sponsor procedures.
- Document and track the management of issues and deviations identified during and between site visits.
- Support investigational site staff in the resolution of issues/deviations and the development of Corrective and Preventive Action (CAPA) plans.
- Collaborate with Biometry, Regulatory Affairs, and Safety departments to obtain necessary site documentation.
- Key Interfaces: All departments within the Operations area.
Education
- University de...
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