Clinical Research Project Manager

Metropolis Healthcare Limited is seeking a detail-oriented and experienced Clinical Research Project Manager to oversee end-to-end clinical study operations, ensuring efficient project setup, execution, and closure in compliance with regulatory and quality standards. The involves coordinating with cross-functional teams, managing client interactions, supporting audits, driving training initiatives, and ensuring timely and accurate delivery of study outcomes while contributing to operational excellence and business growth.

Roles & Responsibilities

• Initiate and manage end-to-end project setup activities post study award.
• Review study protocols against client quotations and seek clarifications from sponsors when required.
• Participate in investigator meetings and support study-related discussions with sponsors.
• Assign and supervise Project Executives for study setup and execution.
• Train study teams on protocols, SOPs, and organizational processes.
• Coordinate with IT teams for system integrations and data transfer setup.
• Support site initiation visits (SIV) or provide remote training to investigator sites.
• Oversee customization of study documents including TRFs, LIMS setup, test profiles, and dummy reports.
• Ensure timely creation of client codes and logistics setup for sample handling.
• Monitor that project setup activities are completed before First Patient First Visit (FPFV).
• Ensure timely release of test reports within defined turnaround times (TAT).
• Monitor communication of critical results, alerts, and deviations to clients/patients with proper documentation.
• Review and track problem samples and ensure timely resolution and reporting.
• Ensure proper maintenance of specimen status, kit inventory, and study documentation.
• Act as a point of contact for sponsor and investigator queries and provide timely resolutions.
• Coordinate with laboratory teams for technical query resolution and result clarifications.
• Conduct regular governance calls and teleconferences with sponsors to provide study updates.
• Review and quality check electronic data files before submission to sponsors.
• Ensure compliance with SOPs, regulatory guidelines, and sponsor requirements throughout the study lifecycle.
• Support QA teams during audits by maintaining updated and audit-ready documentation.
• Manage complaints and grievances, ensuring timely escalation, CAPA generation, and client communication.
• Drive automation and process improvements for operational efficiency.
• Facilitate training and induction programs for new team members.
• Upskill teams on new systems, tools, and process enhancements.
• Monitor MIS reports and analyze performance metrics for continuous improvement.
• Ensure strong coordination between technical and non-technical teams.
• Oversee study close-out activities including data reconciliation and document review.
• Perform QC checks of all study documents prior to archival.
• Ensure proper archival of study-related documentation as per guidelines.
• Contribute to innovation initiatives and support revenue growth opportunities.
• Maintain high standards of quality, compliance, and data integrity across all projects.