Associate Director, CDM Trial Lead, GDMS Clinical Data Management

About the role

The Associate Director, CDM Trial Lead is responsible for end‑to‑end delivery of clinical data management activities across assigned studies. Reporting to Therapeutic Area leadership, the role ensures data quality, integrity, and regulatory compliance while providing strategic oversight throughout the trial lifecycle.

Key responsibilities

• Lead clinical data management from study start‑up through database lock and archival, adhering to SOPs, ICH‑GCP, and protocol requirements.
• Design, review, and validate data collection tools across multiple data sources, including EDC, eCOA, digital health technologies, and external laboratory data.
• Develop and execute data validation and query strategies, collaborating with site monitoring and medical monitoring teams.
• Perform risk‑based data quality oversight, identify systemic trends, conduct root‑cause analysis, and implement mitigation plans.
• Oversee development and maintenance of core deliverables such as Data Management Plans, Data Validation Plans, eCRFs, specifications, and database lock documentation.

Required profile

• Extensive experience in clinical data management within the pharmaceutical or biotech industry, preferably at a senior or leadership level.
• Strong project management skills with the ability to plan, execute, and manage risks across complex, multi‑disciplinary teams.
• Fluent English with excellent communication and stakeholder‑management abilities.

Required skills

• Proficiency with electronic data capture (EDC) systems and electronic clinical outcome assessment (eCOA) tools.
• Deep knowledge of CDISC standards (CDASH, SDTM, Define‑XML) and controlled terminologies.
• Experience in data reconciliation, integration, and validation across diverse sources (e.g., digital health, imaging, biomarkers).
• Familiarity with 21 CFR Part 11, ICH‑GCP, and privacy regulations.
• Ability to use data visualization and dashboarding tools for monitoring data quality.