Position Description

Job Title: Regional Clinical Trial Manager – (Unblinded Lead and Start-up Specialist)
Location: Gurugram, India
Reports to: Associate Director, Clinical Trial Management

Help IAVI translate science into global health impact as a Regional Clinical Trial Manager

IAVI is seeking a Regional CTM, India, who will be responsible for the day-to-day operational activities enabling the conduct of clinical trials according to ICH/GCP guidelines. The role will work closely with the Global CTMs, cross-functional study teams, clinical research sites and CROs to support unblinded activities, study start-up and other operational coordination where applicable.

Key Responsibilities:

Unblinded CTM:

Serve as the unblinded lead for assigned blinded studies ensuring appropriate handling and documentation of unblinded information and maintaining the integrity of the study blind. The responsibilities may include but not be limited to:
Reviewing unblinded monitoring visit reports (MVRs)



and working with the CRA to finalize reports within the deadline set in the study Monitoring Plan
Cross-checking information in the unblinded MVR with the randomization list for each study
Leading or supporting investigations into deviations that involve unblinded data
Filing unblinded documents in the TMF and performing reconciliations of unblinded documents in each study TMF as required by the Document Management Plan
Reviewing laboratory test results or other study information that may be unblinding
As required, liaising with the IAVI Manufacturing and clinical research sites to enable adequate and timely IP supplies at sites

Study Start-up:
Perform study start-up activities as assigned by the Clinical Trial Manager or Director, Clinical Operations. These may include but not be limited to:
Coordinating site feasibility questionnaires and collating responses
Liaising with selected sites to collect required documents for regulatory and ethics submissions
Revie

📌 Regional Clinical Trial Manager Gurugram
🏢 IAVI External
📍 Gurugram