03 Oct
|
IAVI External
|
Gurugram
03 Oct
IAVI External
Gurugram
Position Description
Job Title: Central Monitor
Location: Gurugram, India
Reports to: Associate Director, Clinical Trial Management
Help IAVI translate science into global health impact as a Central Monitor
IAVI is seeking a Central Monitor in India, who will be responsible for leading and supporting centralized monitoring and risk-based monitoring activities for IAVI-sponsored clinical trials. This role will closely work with the global Clinical Trial Managers (CTMs) and cross-functional study team members to support ongoing, data-driven oversight of study and site risks.
Key Responsibilities:
Lead risk-based and central monitoring activities for assigned IAVI-sponsored clinical trials in accordance with the Monitoring Plan, Risk Management Plan and other study-specific plans. This may include but not limited to:
Conduct ongoing review and analysis of clinical trial data listings as defined in the Monitoring Plan to identify missing or inconsistent data, data outliers, unusual trends or distributions, potential protocol deviations, data quality concerns,
safety signals and site performance issues.
Track the status of site KRIs and other risk indicators defined in the Risk Management Plan and assess changes or trends over time.
Integrate findings from KRI review, data-listing analysis and other relevant study information to assess site and overall study risk.
Coordinate and lead central monitoring review meetings as per frequency defined in the Monitoring Plan.
Prepare and maintain Central Monitoring Reports documenting the results of central monitoring activities, identified risks, trends, findings and recommended actions.
Work with the Clinical Trial Manager and relevant functional teams to investigate identified issues, understand potential root causes and determine appropriate and actionable follow-up.
Escalate potential concerns and other significant or critical findings to the appropriate study team members, where appropriate.
Lead or sup
📌 Central Monitor Gurugram
🏢 IAVI External
📍 Gurugram