Senior Operations Manager - Clinical Research

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.