Responsibilities
- Clinical Trials Management:
- Ensure clinical trials are conducted per protocol, local regulatory requirements, ICH GCP, and ethical standards.
- Act as the primary communication point between Sun Pharma and clinical trial sites regarding site management activities.
- Facilitate regulatory submissions and ensure timely IRB/IEC dossier preparation and submission.
- Perform site feasibility assessments and maintain the site database with updated feasibility results.
- Plan and conduct Site Selection Visits (SSVs) and ensure follow-up actions are completed.
- Document and Budget Management:
- Review translated study documents.
- Negotiate study budgets with sites and ensure timely execution of Clinical Trial Agreements (CTAs).
- Process site invoices and track site-related payments.
- Ensure accurate and timely updates of site-related details in essential systems.
- Site and Study Oversight:
- Perform Site Initiation Visits (SIVs) and provide training to the study team.
- Plan and conduct Onsite Monitoring Visits as per the Site Monitoring Plan and follow up on action items.
- Provide periodic updates on study progress, risks, and quality to RTLs and management.
- Collaborate with cross-functional units to ensure efficient study conduct.
- Manage IMP supplies and coordinate with RTLs & Trial Operation Managers for supply orders.
- Track and manage study protocol-required supplies at the sites.
- Plan and track recruitment/retention strategies and communicate recruitment risks to RTLs.
- Compliance and Quality Assurance:
- Ensure compliance with onsite visits, action items, and SAE reporting requirements.
- Prepare sites for audits, inspections, and quality/oversight visits.
- File all essential documents in ITF and TMF.
- Perform site closeout visits and ensure follow-up as per defined processes.
- Communicate/escalate compliance issues and trends to RTLs.
- Maintain healthy relations and effective communication with the site team.
- Plan and manage Investigator meetings.
- Out-sourced Trials:
- Conduct accompanied visits with CRO monitors to ensure quality, PI oversight, and site management.
