Associate Director, Clinical Data Management Trial Lead

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 global 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 [electronic data capture] or DDC [Direct Data Capture]), with accountability for end-to-end integrity across sources and documented rationale for resolution decisions. Own risk-based data quality oversight for assigned studies; identify systemic trends and operational risks, accountable cross-source root-cause analysis, implement mitigation plans, and escalate strategically with clear options and impact to protect timelines, quality, and inspection readiness. Responsible for overseeing data acquisition and integration activities, including data acquisition tool configuration/design inputs, end-to-end data flow validation, and development/maintenance of data integration and/or data cleaning validation specification, in alignment with the protocol, regulations leveraging industry and company standards. Ensure specimen and specialty data strategy and operating model are integrated into the trial’s end-to-end data approach; oversee delivery expectations across vendors/partners. Ensure protocol-aligned laboratory data setup and oversight, including confirmation that laboratories apply protocol-appropriate normal ranges; ensure documentation and supporting evidence are complete and filed within the study record. Oversee the development, review, approval, execution, and maintenance of core data management deliverables, including (as applicable) the Data Management Plan (DMP), Data Validation Plan (DVP), electronic case report forms (eCRFs), specifications, User Acceptance Testing (UAT) documentation, medical coding plans, database lock documentation, and archival readiness documentation to ensure protocol fit, compliance, and inspection readiness, aligned to Trial Master File (TMF) expectations. Accountable for User Acceptance Testing (UAT) and own change control activities across the study lifecycle for relevant systems, tools, and data flows, ensuring requirements, test evidence, approvals, and traceability are complete. Ensure the implementation of data standards (as applicable), including Clinical Data Interchange Standards Consortium (CDISC) standards (e.g., Study Data Tabulation Model (SDTM), Clinical Data Acquisition Standards Harmonization (CDASH)) and controlled terminology, contributing to mapping/specification development and end-to-end traceability across sources. Ensure clinical data management activities comply with privacy and company policies, Title 21 Code of Federal Regulations Part 11 (21 CFR Part 11), and applicable sponsor and health authority regulations and standards, supporting data quality and inspection readiness. Actively represent data management on the Clinical Trial Team (CTT) and in governance forums, ensuring effective input into decision-making from protocol design through central data monitoring and analysis; guide cross-functional execution, decision-making, and issue escalation. Provide oversight, mentoring, and training to Clinical Data Managers (CDMs) and External Data Specialists (EDS). Foster a culture of knowledge sharing and capability building. Facilitate complex functional and cross functional meetings resulting in documented decisions and action plans. For trials originating from acquisitions, partnerships, or outside standard processes, plan and oversee end-to-end data management while ensuring compliance, quality, and inspection readiness; liaise with partner organizations, service providers, and governance bodies, documenting decisions and ensuring compliant processes and tools even when operating models differ from in-house approaches. Contribute expertise, project management, and/or leadership to additional projects and continuous improvement initiatives, including (but not limited to) process, standards, and platform / tool efforts. Technical Skills: Deep understanding of the clinical development lifecycle, data flow, and cross-functional dependencies (e.g., Clinical Operations, Biostatistics, Safety, Data Standards, and Regulatory). Strong command of clinical data management platforms and enabling technologies, including electronic data capture (EDC) systems and other data acquisition tools (e.g. eCOA), query management, data reconciliation/integration, and data visualization/dashboarding tools. Extensive experience designing, validating, and maintaining integrated data management deliverables and validation components to ensure accuracy, auditability, and compliance. Demonstrated Understanding of Clinical Data Interchange Standards Consortium (CDISC) standards (e.g., Clinical Data Acquisition Standards Harmonization (CDASH), Study Data Tabulation Model (SDTM), Define-XML), metadata management, and controlled terminologies to ensure data consistency and submission readiness. Quality, compliance, and risk orientation with working knowledge of Standard Operating Procedures (SOPs), International Council for Harmonization – Good Clinical Practice (ICH-GCP), Title 21 Code of Federal Regulations