• 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 a...