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.
Positive 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 (India)
🏢 Sunshine Group
📍 India