Executive Director, Clinical Data Management TA Head, EDEV & OED Lead

Merck•Rahway, NJ

2d•$231,900 - $365,000•Hybrid

About The Position

Reporting directly to the Head of Clinical Data Management and serving as a member of the Clinical Data Manager Leadership Team, the Executive Director, Clinical Data Manager TA Head provides global leadership and strategic direction for one or more therapeutic areas. The role defines and executes the TA strategy, operating model, and innovation roadmap to ensure scalability, quality, and enterprise alignment across GDMS. The Executive Director represents the TA organization in Clinical Data Manager, GDMS, and enterprise forums, shaping future strategy, driving transformation, and advancing capability development across all geographies.

Requirements

Comprehensive knowledge of the clinical development lifecycle, data flow, and cross-functional dependencies (Clinical Operations, Biostatistics, Safety, Data Standards, Regulatory).
Extensive knowledge in relevant Clinical Data Manager platforms and enabling technologies (EDC, query management, reconciliation/integration, and data visualization/dashboarding).
Extensive experience designing, validating, and maintaining DM (Data Management) deliverables and validation components to ensure accuracy, auditability, and compliance.
Deep understanding of clinical practice and medical terminology, enabling effective data interpretation and timely issue resolution.
Working knowledge of SOPs, ICH-GCP (International Council for Harmonization – Good Clinical Practice), 21 CFR Part 11/Annex 11, and privacy expectations; applies risk-based, data-driven approaches (RBQM [Risk Based Quality Management]) to prevent/mitigate issues.
Strong analytical and problem-solving skills, with the ability to operate in ambiguity, apply critical thinking, and develop innovative, compliant solutions.
Demonstrated expertise within all assigned TAs within scope applying TA-specific scientific and operational knowledge to shape data management strategy and decision-making at the TA-level.
Mastery of enterprise-level data management methods, frameworks, and regulatory environments.
Expertise in data architecture, standards governance, and performance metrics design and interpretation.
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 and Codes]) to ensure consistency and submission readiness.
Expertise in defining and interpreting capability-level (L1–L3) metrics, dashboards, and diagnostics.
Demonstrated experience implementing digital, automation, and analytics initiatives to support TAs and across functions.
In-depth understanding of enterprise audit-readiness, inspection, and global risk frameworks.
Ability to integrate innovation, technology, and business strategy to shape the long-term data management vision.
Excellent organization and prioritization with demonstrated ability to manage deliverables across several distinct programs / projects.
Executive communication and storytelling skills, with the ability to influence senior leadership decisions.
Demonstrated strategic, enterprise leadership and cross-functional orchestration across geographies and disciplines.
Ability to lead through influence and motivate cross-functional and geographically diverse teams.
Demonstrated ability to applying governance judgment balancing compliance, quality, delivery, and innovation.
Data-informed decision-making with an enterprise mindset and strategic foresight.
Demonstrate inspirational and transformative leadership fostering collaboration, inclusion, and accountability globally.
Ability to shape culture, guide transformation, and build organizational capability at scale.
Ability to integrate business, operational, and people dimensions to effective decision-making.
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.
Talent Growth | Establishes the systems, processes, and work environment needed to attract, develop, engage, and retain talented individuals, enabling people to realize their full potential and the organization to meet current and future industry challenges.
Strategic Planning | Identifies and evaluates the key issues, trends, and cross-functional interdependencies most relevant to long-range goals. Uses facts, assumptions, resource constraints, and organizational priorities to define an effective path forward that supports the long-term success of the Clinical Data Manager organization.
Bachelor's Degree in Nursing, Pharmacy, Life sciences, Allied Health, Data / Information technology or Medical Technology with 15 years of experience in clinical data management, clinical trial operations or related field, including 10 years of people management experience. Demonstrate deep SME (Subject Matter Expert) in relevant discipline.
OR Advanced Degree (preferred) (Masters or Doctorate) in Nursing, Pharmacy, Life sciences, Allied Health, Data / Information technology or Medical Technology with 13 years of experience in clinical data management, clinical trial operations or related field, including 10 years of people management experience. Demonstrate deep SME in relevant discipline.
AND Demonstrated experience in leading geographically-diverse cross-functional teams in delivery of clinical data management or clinical trial operations strategy, execution and submissions (Inspections & Health Authority Interactions & Responses).

Responsibilities

Serve on the Clinical Data Manager (Clinical Data Management) Leadership Team and represent the Therapeutic Area across GDMS (Global Data Management & Standards), GCTO (Global Clinical Trial Operations), GCD (Global Clinical Development), and enterprise forums; set, communicate, and align TA (Therapeutic Area) objectives with GDMS strategy.
Ensure Clinical Data Manager products and services meet Book-of-Business commitments for the Therapeutic Area, including Data Acquisition Tools (DAT - e.g., EDC, DHT-eCOA), edit checks, data validation tools, data integrity and review, external data integration, IVRS/IRT (Interactive Voice Response System/ Interactive Response Technology), and interim/final database locks.
Partner with Clinical Data Manager Geographic Leadership to ensure seamless global delivery, effective knowledge sharing, in depth understanding of protocols, risk based data management and quality-by-design execution proportionate to study design and therapeutic area risk management across all in-scope data modalities.
Partner with leaders across GDMS, GCTO, and GCD to drive consistent rollout and adoption of data management capabilities, including alignment of cross-regional ways of working with partners.
Manage the Therapeutic Area Clinical Data Manager Budget under guidance of the Head of Clinical Data Manager; optimize spend, productivity, and resource allocation.
Drive operational performance against cycle-time, quality, efficiency, and delivery commitments.
Embed quality, inspection readiness, and regulatory compliance into TA-level operating models and execution.
Direct the development, maintenance, and adoption of TA-specific standards and business practices to ensure compliance with global regulatory requirements and internal quality standards.
Partner, influence, and advise senior internal and external stakeholders (Clinical, Regulatory, Statistics, Country Operations, investigators, service providers); lead senior-level customer, service provider, and industry engagements.
Sponsor or lead large-scale change and continuous improvement initiatives (including but not limited to process, standards, and platform / tools), driving harmonization of data management practices across the enterprise.
Influence and lead the selection and evolution of data management systems, processes, and operating models to ensure future-ready, scalable capabilities.
Provide strategic input to, and where accountable define, capability development objectives and roadmaps aligned to business needs, enterprise strategy, and industry best practices.
Provide oversight of capability governance in alignment with GDMS and GCTO policies and enterprise digital and data initiatives.
Set the people strategy for the TA; develop leaders; ensure global role clarity and decision rights; maintain a resilient, inclusive, high-performance culture.
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.
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.