Role Purpose To lead and manage all clinical data management activities across multiple clinical trials, ensuring high quality, compliant, and timely delivery of data in accordance with regulatory requirements, SOPs, and project specifications.

Detailed Responsibilities
Lead end-to-end clinical data management activities from study start-up to database lock and closeout
Act as the single point of contact for multiple studies, coordinating with clients and cross-functional teams (Biostatistics, Programming, Medical, Safety, QA, Vendors)
Ensure preparation, review, and maintenance of all clinical data management documents (DMP, CRF Completion Guidelines, Validation Plans, etc.)
Manage client communication regarding timelines, deliverables, and project updates
Maintain study files in an audit-ready state at all times
Allocate, monitor, and review tasks for data management team members to ensure quality and timeline adherence
Collaborate with internal stakeholders and functional leads to ensure smooth project execution




Serve as escalation point for unresolved data issues and ensure timely resolution
Ensure appropriate resource planning and allocation across projects
Ensure compliance with DMP, SOPs, and contractual obligations (SOW)
Implement and oversee quality management plans; track performance and drive corrective actions
Identify prospects for process improvement and lead implementation initiatives
Train, mentor, and develop team members in data management and medical coding
Coordinate with third-party vendors (CDMS, medical coding dictionaries, labs, etc.)
Ensure data accuracy, reliability, and readiness for analysis and regulatory submission
Oversee CRF design, database development, edit checks, UAT, and medical coding processes
Supervise data cleaning, reconciliation, query management, and interim data reviews
Manage database freeze, lock, and archival activities

📌 Associate Team Lead Clinical Data Management Pune
🏢 ProRelix Services
📍 Pune