Position: Senior Operations Manager – Clinical Research

Experience: 6–10 Years

Location : Nagpur

Key Responsibilities:

- Manage clinical research operations across multiple studies/sites.
- Oversee study start-up, site activation, conduct, closeout and documentation.
- Track recruitment, timelines, milestones and site performance.
- Lead and guide Project Managers, CRCs and clinical operations teams.
- Coordinate with PIs, sponsors, CROs, QA and Regulatory teams.
- Ensure compliance with ICH-GCP, SOPs, protocols and regulatory requirements.
- Manage operational risks, deviations, CAPA and issue resolution.
- Review TMF/eTMF, CTMS, EDC, reports and study trackers.
- Prepare operational dashboards and reports for senior management.
- Support audits, inspections, budgeting, vendors and process improvements.

Required Skills:

- Education: Bachelor’s/Master’s in Life Sciences, Pharmacy, Nursing, Biotechnology, Medicine,



Healthcare Management or related field.
- Solid clinical trial operations and site management experience.
- Good knowledge of ICH-GCP and regulatory compliance.
- Team leadership, stakeholder management and problem-solving skills.
- Experience with CTMS, EDC, eTMF and MS Office.

Pay: ₹80,000.00 - ₹90,000.00 per month

Application Question(s)

- Do you have 6–10 years of experience in Clinical Research/Clinical Operations, ICH-GCP compliance, site activation, patient recruitment, study closeout, CTMS/EDC/TMF/eTMF, and coordination with Sponsors, CROs, PIs and CRCs?

Experience:
- managing multiple studies/sites,: 2 years (Required)

License/Certification:
- ICH-GCP certification (Required)

Work Location: In person

📌 Senior Operations Manager – Clinical Research (Nagpur)
🏢 Sunshine Group
📍 Nagpur