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 typesdefined 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 trials 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 Part 11 (21 CFR Part 11) and Annex 11 and privacy requirements; apply risk-based data-driven approaches (e.g. Risk-Based Quality Management (RBQM)) to prevent or mitigate issues.
• Solid foundation in clinical practice and medical terminology supporting effective data interpretation and timely issue resolution.

Non-technical Skills:

• Effective Project Manager that excels at planning execution and risk management including identification of Critical to Quality factors related to data management. Sets priorities across teams and workstreams; drives alignment to organizational priorities and delivery commitments.
• Effectively facilitates cross functional discussions to ensure robust and timely decisions.
• Fluent in English with exceptional communication and influencing skills across functions geographies and organizational levels; clearly conveys complex topics to diverse audiences.
• Strong stakeholder management and collaboration; builds trust and effective partnerships to deliver consistent high-quality outcomes.
• Independent and accountable work style; leads through influence and maintains alignment with leadership direction and strategy.
• Effective facilitator of decision-making; coordinates the work of others and drives timely resolution of complex issues.
• Builds and scales capability through mentoring coaching and knowledge-sharing; motivates and guides teams without direct authority.
• High adaptability and resilience; performs effectively under pressure in fast-changing environments while maintaining alignment.

Enterprise Leadership Skills:

• Networking & Partnerships Builds and maintains effective working relationships across teams and functions to access the knowledge experience resources and influence needed to support team success and advance work goals.
• Executional Excellence Focuses on delivering results in accordance with compliance standards by setting clear priorities aligning others on the most critical work monitoring progress and ensuring accountability for outcomes.
• Influence Uses effective involvement and persuasion strategies to build alignment and gain commitment to actions that support team success and advance work outcomes.

Qualifications & Experience:

• Non-Degree or associates degree (preferred in Nursing Pharmacy Life sciences Allied Health Data / Information technology or Medical Technology) with minimum 10 years of directly relevant experience working in data management clinical trial operations or related field.

OR

• Bachelors Degree (preferred in Nursing Pharmacy Life sciences Allied Health Data / Information technology or Medical Technology; or equivalent education experience) with minimum 8 years of experience working in data management clinical trial operations or related field.

OR

• Advanced Degree (Masters or Doctorate) (preferred in Nursing Pharmacy Life sciences Allied Health Data / Information technology or Medical Technology) with minimum 4 years of experience working in data management clinical trial operations or related field.

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