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Clinical Data Manager -II

Location

Chennai, Tamil Nadu, India

JobType

full-time

About the job

Info This job is sourced from a job board

About the role

Support DM-related activities and collaborate with Lead DMs, Clinical Programmers, Data Scientists, Clinical Monitoring teams, and other functions like Project Management, Clinical Operations, and Biostatistics

• Provide regular updates to Lead DM on progress, timelines, risks, and quality; support resource planning when assigned as Lead CDM

• Track tasks against budget and forecasts; identify and initiate scope change requests when required

• Develop, review, and maintain key DM documents such as DMP, eCRF specifications, DVP, and external data transfer agreements

• Support or lead clinical database setup, including eCRF design and validation requirements

• Participate in reviewing study documents like protocols, project plans, safety plans, and statistical analysis plans

• Coordinate and complete User Acceptance Testing (UAT) activities for databases

About the company

Global contract research organization providing drug development services for biopharma.

Skills

EDC
eCRF
Data Management System
Quality Assurance