Associate Team Lead - Clinical Data Management

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 opportunities 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