Responsibilities
Manage and oversee day-to-day clinical research operations across assigned studies and

sites.
Coordinate end-to-end study activities from study start-up and site activation through

study conduct, closeout, and archiving.
Develop and track operational plans, study timelines, milestones, recruitment/enrolment

targets, and site deliverables.
Supervise and guide Project Managers, Clinical Research Coordinators (CRCs), and other

clinical operations personnel.
Monitor site performance, patient recruitment/enrolment, protocol compliance,

documentation, and operational deliverables.
Coordinate with Principal Investigators, Sub-Investigators, site teams, sponsors, CROs,

and internal departments for smooth study execution.
Oversee site feasibility, readiness, activation, training, study supplies, essential

documents, and other start-up requirements.
Review study trackers, reports, TMF/site documentation, and operational records for

completeness and timely updates.
Identify operational risks, delays, deviations, and critical issues and ensure timely

escalation and resolution.
Support monitoring visits, sponsor/CRO meetings, audits, inspections, and follow-up

actions.
Ensure timely implementation and tracking of corrective and preventive actions (CAPA)





related to operational issues.
Coordinate with Quality Assurance and Regulatory Affairs to maintain compliance with

ICH-GCP, SOPs, protocols, and applicable regulatory requirements.
Review resource requirements, workload allocation, staffing needs, and operational

priorities and provide recommendations to management.
Prepare and present study status reports, dashboards, performance updates, and

operational summaries to senior management.

Key Performance Measurement Indicators
Achievement of study timelines, milestones, recruitment/enrolment targets, and

operational deliverables.
Site and team performance against defined operational KPIs.
Quality and completeness of study documentation, TMF/site files, and audit readiness.
Compliance with ICH-GCP, SOPs, protocols, and applicable regulatory requirements.
Timeliness and effectiveness of issue, deviation, risk, and CAPA management.
Team productivity, coordination, training effectiveness, and resource utilization.
Sponsor, CRO, investigator, and internal stakeholder feedback.
Timely and accurate reporting, dashboard maintenance, and management updates.
Successful implementation of process improvements and operational efficiency

initiatives.

📌 Senior Operations Manager Clinical Research Nagpur (India)
🏢 Riddhi Siddhi Career Point
📍 India