indeed
Clinical Research Project Manager
Metropolis Healthcare India
Maharashtra, IND
Full-time
Onsite
Discovered 1 weeks ago
Clinical trial project managementClinical trial project setupProtocol trainingStudy documentation and archivalQuality controlStandard operating procedures
Free
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Clinical trial project managementClinical trial project setupProtocol training
Role Overview
Support QA teams during client and study audits by keeping updated documentation available for review.
Lead training and induction on SOPs, laboratory processes, organizational functions, and system advancements.
Coordinate client governance, cross-functional laboratory collaboration, complaint management, compliance, and MIS monitoring.
Key Skills for This Role
Clinical trial project managementClinical trial project setupProtocol trainingStudy documentation and archivalQuality controlStandard operating procedures
Full Job Posting
Role summary
Support QA teams during client and study audits by keeping updated documentation available for review.
Lead training and induction on SOPs, laboratory processes, organizational functions, and system advancements.
Coordinate client governance, cross-functional laboratory collaboration, complaint management, compliance, and MIS monitoring.
Project setup
- Initiate study setup after award, review the protocol against the quote, obtain sponsor clarifications, and document decisions.
- Participate in sponsor investigator meetings and assign project staff for setup and project management activities.
- Train the study team on the protocol and coordinate data transfer setup with IT when applicable.
- Supervise customization of TRFs, laboratory information systems, test profiles, and dummy reports.
- Request client codes, coordinate specimen logistics, and ensure setup is complete before first patient first visit.
Project management
- Monitor report release within committed turnaround times and ensure important alerts and results are communicated and documented.
- Monitor problem data, problem specimens, specimen status, and kit inventory, ensuring timely follow-up and updates.
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