Senior Operations Manager – Clinical… at Sunshine Group · Nagpur

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.
• Strong 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