Job Description

Under the direction of Therapeutic Area (TA) leadership, the CDM (Clinical Data Management) Trial Lead is accountable for end-to-end delivery of data management activities for assigned studies, ensuring quality, integrity, and compliance with GDMS standards and regulatory requirements. The role provides strategic and operational oversight across the trial lifecycle, serves as the primary data management contact for cross-functional teams, and contributes to process improvement and capability development within the general GDMS community.

Responsibilities

• Lead end-to-end clinical data management activities for assigned studies from study start-up through database lock and archival in accordance with defined processes, timelines, quality targets, Standard Operating Procedures (SOPs), International Council for Harmonization – Good Clinical Practice (ICH-GCP), and protocol-specific requirements; partner with assigned leadership for alignment on strategy, risks, and escalations.




• Oversee clinical data collection design and review across all data types—defined as reconciliation, logical consistency review, and remediation of study data from multiple sources and data types. Responsible for ensuring that study protocol is effectively translated into data management deliverables and tools. Develop data validation and query strategy for execution to clinical sites and service providers through resolution in collaboration and alignment with Site Monitoring and Medical Monitoring, ensuring timely closure and documented rationale.
• Oversee team reviewing, validating, and reconciling data within and across clinical trial data sources and environments, which may include (but not limited to) digital health technologies (DHT), electronic clinical outcome assessments (eCOA), electronic external data (e.g., central laboratories, imaging, biomarkers), vendor/service provider portals, and the clinical database including site entered or transferred data (e.g., EDC [

📌 Associate Director, CDM Trial Lead, GDMS Clinical Data Management (Guaduas)
🏢 MSD LATAM
📍 Guaduas