Associate Director, CDM Trial Lead – Clinical Data Management

About the role

The Associate Director, CDM Trial Lead is responsible for end‑to‑end delivery of clinical data management activities for assigned studies, ensuring data quality, integrity and regulatory compliance across the trial lifecycle.

Key responsibilities

• Lead all data management tasks from study start‑up through database lock and archival, adhering to SOPs, ICH‑GCP and protocol requirements.
• Design and review data collection tools, develop validation and query strategies, and oversee reconciliation of data from multiple sources including digital health technologies, eCOA, labs and imaging.
• Provide risk‑based data quality oversight, perform root‑cause analysis, implement mitigation plans and ensure inspection readiness.
• Manage data acquisition tool configuration, integration validation and specimen data strategy, coordinating with vendors and service providers.
• Develop and maintain core deliverables such as Data Management Plans, eCRFs, specifications, UAT documentation and CDISC mappings.
• Represent data management in cross‑functional trial teams and governance forums, and mentor junior CDMs and External Data Specialists.

Required profile

• Extensive experience in clinical data management across the full drug development lifecycle.
• Strong knowledge of regulatory standards (ICH‑GCP, 21 CFR Part 11) and risk‑based quality management.
• Proven ability to lead multi‑disciplinary teams and manage complex projects.

Required skills

• Electronic Data Capture (EDC) systems and electronic clinical outcome assessment (eCOA) tools.
• Clinical Data Interchange Standards Consortium (CDISC) standards – CDASH, SDTM, Define‑XML.
• Data validation, query management, data reconciliation and integration.
• User Acceptance Testing (UAT) and change control processes.
• Data visualization/dashboarding tools.