Area of Responsibility:
- Ensure clinical trials at assigned sites follow protocol, local regulations, ICH GCP, data integrity, patient safety, and ethical standards.
- Serve as the primary communication point between Sun Pharma and the clinical trial site for site management activities.
- Facilitate regulatory submissions and perform site feasibilities.
- Conduct Site Selection visits and follow up on actions with the assigned team.
- Plan and perform IRB submissions to secure timely approvals and ensure IRB/IEC dossiers are prepared and submitted as required.
- Review translated study documents and negotiate study budgets with sites.
- Ensure Clinical Trial Agreements are executed timely and site invoices are processed per the executed CTA.
- Update site-related details in essential systems timely and accurately.
- Conduct Site Initiation Visits (SIV) and training for the study team.
- Plan and conduct Onsite Monitoring Visits per the Site Monitoring Plan.
- Provide periodic updates to RTLs and management on study progress, deliverables, risks, and quality.
- Collaborate with cross-functional units (Quality, Data Management, Medical team, and other stakeholders).
- Ensure adequate IMP supplies at sites and manage IP supply schemes.
- Plan and track recruitment/retention strategies at the site.
- Ensure compliance with Onsite visits, action items, PD & SAE reporting requirements.
- Ensure site readiness for audits, inspections, and quality/oversight visits.
- Review and file all essential documents in ITF and TMF.
- Perform site closeout visits and follow up as per the defined process.
- Maintain healthy relations and effective communication with the site team.
- Play an active role in planning and managing Investigator meetings.
Candidate Profile:
- Minimum Pharmacy Graduate (B.Pharm) or Post Graduate (M.Pharm) in pharmacy or other science/healthcare fields.
- Additional qualifications are preferred.
- At least 3 years of experience in clinical research and at least 2 years of onsite monitoring experience for Phase II/III global clinical trials.
Additional Information:
- Experience: 2-3 years
- Qualification: B.Pharm / M.Pharm
- Location: Gurgaon – R&D
- Industry Type: Pharma / Healthcare / Clinical research
- End Date: 30th July 2024
This is an exciting opportunity to contribute to groundbreaking clinical research while working with a leading pharmaceutical company.