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.
Qulification & 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.
| Experience | 6 - 10 Years |
| Salary | 9 Lac To 12 Lac P.A. |
| Industry | Pharma / R&D / Biotech |
| Qualification | B.Pharma, B.Sc |
| Key Skills | Study Design Patient Recruitment Good Clinical Practice Budget Management Clinical Monitoring Vendor Management Quality Control |
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