Associate Director, CDM Trial Lead, GDMS Clinical Data Management

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 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

·       Bachelor's 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.

Required Skills:

Adaptability, Adaptability, Clinical Database Programming, Clinical Data Management, Clinical Data Standards, Clinical Research, Data Analysis, Data Compliance, Data Integrity, Data Management, Data Quality Assurance, Data Reporting, Data Standards, Data Validation, Delivery Management, Detail-Oriented, Documentation Preparation, Enterprise Leadership, Expectation Management, Goal Setting, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Influencing Skills, Interpersonal Relationships, Knowledge Sharing {+ 8 more}

Preferred Skills:

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Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

NA

Job Posting End Date:

10/16/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.