Executive Director, Clinical Data Management TA...

Under the direction of Clinical Data Manager and Global Data Management and Standards (GDMS) leadership, the Executive Director, Clinical Data Manager TA/ Indication Lead provides operational leadership for data management delivery within an assigned indication(s) for a therapeutic area.

The role oversees day-to-day portfolio execution, resource management, and risk and quality oversight to ensure timely, compliant, and high-quality delivery of study and program data. The Executive Director partners cross-functionally across Clinical, Biostatistics and Research Data Science (BARDS), Global Data Integration and Automation (GDIA), and Global Clinical Data Standards (GCDS) to ensure consistent standards application, operational excellence, and capability development within the TA.

Primary Responsibilities:

• Own day-to-day TA (Therapeutic Area) delivery, ensuring high-quality, on-time study and program outputs across all data modalities and tools (eCRF [electronic Case Report Form], labs, biomarkers, eCOA [electronic Clinical Outcome Assessment], imaging, EDC etc.).

• Act as the primary operational link among TA Leads, Program Leads, and Functional Area Geo Leaders; coordinate readiness for key milestones (e.g., First Site Ready, First Patient Enrolled, database lock).

• Support acquisitions, partnerships, and due diligence activities as requested, ensuring operational continuity and data readiness.

• Track TA Book of Business and demand.

• Proactively initiate resourcing at the appropriate time and balance workload and capacity across studies and geographies to meet delivery commitments.

• Monitor TA performance metrics (e.g., data currency, query aging, lock timeliness).

• Lead TA-level risk reviews, trigger CAPAs as needed, and ensure effective follow-through.

• Drive consistent use of GDMS (Global Data Management & Standards) standards, tools, and processes, ensuring SOP (Standard Operating Procedure), ICH-GCP (International Council for Harmonization - Good Clinical Practice), study protocol and regulatory adherence.

• Ensure documentation completeness and consistency; support audits and inspections across studies.

• Represent the TA in relevant governance and oversight forums (e.g., TAST [Therapeutic Area Standards Team], TA DRC [Data Review Committee]).

• Promote collaboration and continuous improvement across Clinical Data Manager (Clincal Data Management) teams, driving alignment, standardization, and shared learning.

• Support the development and maintenance of TA-specific onboarding and training to build consistent capability across the TA.

• Contribute expertise, project management, and/or leadership to additional projects and continuous improvement initatives, including (but not limited to) process, standards, and platform / tool efforts.

• Set clear objectives aligned to organizational goals; assign work and set priorities.

• Conduct regular check-ins and annual reviews; coach for performance; provide recognition.

• Develop career plans; create growth opportunities and promotion cases; ensure appropriate training and mentoring.

• Coach and develop team members, identifying skill gaps and development needs.

• Lead recruiting and hiring; manage sensitive employee-relations matters in partnership with HR.

• Balance workloads to support value-added work and work-life sustainability; anticipate obstacles and adjust plans.

• Coordinate on-shore/off-shore and contingent resources; ensure role clarity and effective handoffs.

• Manage an operating budget and optimize spend against priorities.

• Align teams around a clear direction; facilitate team/functional meetings.

• Provide concise, decision-ready updates and status reporting to leadership and partners.

• Deep experience leading end-to-end clinical data management for trials, including database design/build, UAT (User Acceptance Training), edit checks and validation, data review and reconciliation, and database lock.

• Extensive experience authoring, validating, and maintaining data management deliverables and validation components to ensure accuracy, auditability, and inspection readiness.

• Deep understanding of data structures, integrations, and data flow across EDC (Electronic Data Capture) and connected systems (e.g., labs, IRT [Interactive Response Technology], eCOA, imaging), with a proven ability to triage and resolve study-level issues across internal systems and service providers.

• Extensive knowledge of Clinical Data Manager platforms and enabling technologies, including EDC, query management, reconciliation/integration tools, and data visualization/dashboarding.

• Advanced Therapeutic Area expertise, applying TA-specific scientific and operational knowledge to shape data management strategy and decision-making at the indication and TA level.

• Comprehensive understanding of the clinical development lifecycle, clinical practice, and medical terminology, with strong awareness of cross-functional dependencies (Clinical Operations, Biostatistics, Safety, Data Standards, Regulatory).

• Advanced proficiency in CDISC (Clinical Data Interchange Standards Consortium) standards (CDASH [Clinical Data Acquisition Standards Harmonization], SDTM [Study Data Tabulation Model], Define-XML), metadata management, and controlled terminologies (e.g., LOINC [Logical Observation Identifiers Names & Codes])

• Strong working knowledge of SOPs, ICH-GCP, 21 CFR Part 11/Annex 11, and privacy expectations, applying risk-based, data-driven approaches (RBQM [Risk Based Quality Management]).

Non-Technical Skills

• Exceptional communication and collaboration skills, enabling effective leadership across cross-functional and global teams.

• Ability to lead through influence, align stakeholders, and motivate teams around shared objectives.

• Strong leadership presence with demonstrated people leadership, mentoring, and coaching capabilities across multiple levels and geographies.

• Sound judgment and accountability, integrating business, operational, and people considerations to make effective decisions within operational constraints.

• Strong organizational and prioritization skills, able to manage multiple, competing deliverables while maintaining focus on critical outcomes.

• Commitment to continuous improvement, fostering a culture of operational excellence, accountability, and high performance.

• Strong analytical and critical thinking capability, able to operate effectively in ambiguity, synthesize complex information, and develop innovative, compliant solutions to complex data and operational challenges.

Enterprise Leadership Skills

• Networking & Partnerships

  Develops and maintains strategic relationships with internal and external stakeholders to bring forward the information, perspectives, expertise, and influence needed to address issues and advance organizational goals.

• **Coaching & Development

  ** Provides feedback, guidance, and development support to help others excel in current and future roles, while actively building the skills and capabilities needed for individual and organizational success of Clinical Data Manager.

• **Influence

  ** Uses thoughtful influence strategies to build alignment, secure stakeholder commitment, and drive actions that advance shared priorities and business goals., + Advanced Degree (preferred) (Masters or Doctorate) in Nursing, Pharmacy, Life sciences, Allied Health, Data/ Information technology or Medical Technology with 8 years of experience in clinical data management, clinical trial operations or related field, including 3 years of people management experience. Demonstrate deep SME skill in relevant discipline., + Advanced Degree (preferred) (Masters or Doctorate) in Nursing, Pharmacy, Life sciences, Allied Health, Data / Information technology or Medical Technology with 4 years of experience in clinical data management, clinical trial operations or related field, + Demonstrated experience in leading geo cross functional Teams in delivery of clinical data management or clinical trial operations strategy, execution and submissions (Inspections & Health Authority Interactions & Responses)., Budget Management, Clinical Data Management, Clinical Development, Clinical Study Protocols, Clinical Trial Management, Clinical Trials, Cross-Functional Leadership, Data Processing, Data Validation, Electronic Data Capture (EDC), Executive Leadership, Good Clinical Practice (GCP), Operational Excellence, Strategic Direction, Strategic Leadership

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The salary range for this role is

$231,900.00 - $365,000.00

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.