Note: The job is a remote job and is open to candidates in USA. MSD is a pharmaceutical and clinical research organization. The Director, Program Lead, Clinical Data Management oversees program- and portfolio-level clinical data management strategy, execution, quality, compliance, risk management, and resource allocation. The role also provides leadership to cross-functional teams, drives continuous improvement, and develops organizational capability through mentoring and training.
Responsibilities
- Own program- and portfolio-level data management strategy and plans across all data modalities (eCRF [electronic Case Report Form], labs, biomarkers, PRO [Patient Reported Outcome]/eCOA [electronic Clinical Outcome Assessment], imaging, etc.), aligned with development plans, trial protocols, regulatory deliverables, Global Data Management & Standards, and Book of Business–driven resourcing
- Lead risk-based planning, timelines, and inter-study dependencies across larger and more complex portfolios, ensuring consistent data collection, integration, validation, UAT (User Acceptance Training), database lock, and inspection readiness across trials
- Set and govern cross-program data strategy as a Clinical Data Manager (Clinical Data Management)/Subject Matter Expert, ensuring consistent standards, conventions, specifications, and change control across studies and systems
- Drive program- and portfolio-level quality, risk management, RCA/CAPA, audits, inspections, remediation, and complete, traceable documentation and archival
- Lead or sponsor strategic initiatives in data standards, automation, digital enablement, and quality frameworks to improve scalability and efficiency (including but not limited to process, standards, and platform / tools)
- Represent Global Data Management & Standards in program- and portfolio-level forums; partner with Clinical, Biostatistics and Research Data Science, Global Data Integration and Automation, Global Clinical Data Standards, Safety, IT, service providers, and Global Clinical Trial Operations/ Therapeutic Area leadership to align priorities, risks, budgets, and decisions
- Act as the escalation point for complex cross-functional and cross-program issues, providing senior-level decision support and resolution
- Support acquisitions and partnerships through data management due diligence and integration oversight, ensuring data quality and compliance when operating outside standard Clinical Data Manager models
- Build organizational capability through mentoring, training, playbooks, and communities of practice, developing future Global Data Management & Standards and Program Lead leaders
- Establish and use program-level dashboards, KPIs, and analytics to guide execution oversight, service provider engagement, and future deliverables
- Govern service provider performance at the program level, including SLAs (Service Level Agreements), KPIs, QBRs (Quarterly Business Reviews), escalations, and remediation planning
- 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
Skills
- Comprehensive knowledge of the clinical development lifecycle, end-to-end data flow, and cross-functional dependencies across Clinical Operations, Biostatistics, Safety, Data Standards, and Regulatory
- Proven experience leading end-to-end data management across clinical trials, including database design and build, UAT (User Acceptance Training), data validation and reconciliation, and database lock, with accountability for quality, timeliness, and inspection readiness
- Demonstrated experience managing complex portfolios, resource models, and multi-program delivery, balancing quality, risk, timelines, and operational constraints
- Strong proficiency with clinical data management platforms and enabling technologies, including EDC (Electronic Data Capture) and other data acquisition tools (e.g., eCOA), query management, reconciliation and integration workflows, and data visualization or dashboarding tools
- Strong understanding of data structures and integrations across Electronic Data Capture and connected systems (e.g., labs, IRT [Interactive Response Technology], eCOA [electronic Clinical Outcome Assessment], imaging), with demonstrated ability to triage and resolve complex data integrity issues across internal systems and service providers
- Advanced proficiency in Clinical Data Interchange Standards Consortium standards and Clinical Data Acquisition Standards Harmonization, Study Data Tabulation Model, Define-XML), metadata management, and controlled terminologies (e.g., LOINC [Logical Observation Identifiers Names and Codes]), and GDMS standards to ensure consistency, traceability, and regulatory submission readiness
- Deep understanding of data quality frameworks and regulatory expectations, with working knowledge of SOPs (Standard Operating Procedures), ICH-GCP (International Council for Harmonization – Good Clinical Practice), 21 CFR Part 11/Annex 11, and privacy requirements; proven ability to interpret and apply RBQM (Risk Based Quality Management) principles at the program and portfolio level
- Expertise in operational metrics, analytics, and continuous improvement methodologies, with strong analytical and problem-solving skills to operate effectively in ambiguity and develop innovative, compliant solutions
- Exceptional communication and influencing capability, including distilling complex issues into clear, decision-ready narratives and effectively conveying options, risks, and recommendations to senior stakeholders across functions, geographies, and levels
- Demonstrated ability to lead through influence, motivating and guiding cross-functional and virtual teams without direct reporting authority, while aligning senior stakeholders on objectives, interfaces, and responsibility assignments and constructively resolving conflicts
- Proven ability to coordinate decisions across regions and time zones, leveraging asynchronous communication and governance mechanisms to maintain alignment, momentum, and clarity of ownership
- Effective facilitator of complex decision-making, coordinating inputs, driving timely resolution, enforcing clean handoffs, and ensuring decisions translate into clear actions and outcomes
- Highly adaptable and resilient, able to prioritize effectively under pressure in fast-changing environments while driving adoption of standardized ways of working, mobilizing cross-functional champions, and measuring uptake
- Bachelors of Arts or Science (or equivalent educational experience) in Nursing, Pharmacy, Life sciences, Allied Health, Data / Information technology or Medical Technology with 10 years of experience in clinical data management, clinical trial operations or related field. Demonstrate deep SME (Subject Matter Expert) skill in relevant discipline and people management skills
- Bachelors of Arts or Sciences degree (or equivalent educational experience) in any field not listed above with a minimum of 15 years of experience working in data management or clinical trial operations or related field. Demonstrate deep SME (Subject Matter Expert) skill in relevant discipline and people management skills
- Advanced Degree (Masters or Doctorate) in any field not listed above with a minimum of 13 years of experience working in data management or clinical trial operations or related field. Demonstrate deep SME skill in relevant discipline and people management skills
- Demonstrated experience in leading geo diverse cross functional Teams in delivery of clinical data management or clinical trial operations strategy, execution and submissions (Inspections & Health Authority Interactions & Responses)
- 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. Demonstrate deep SME skill in relevant discipline and people management skills
Benefits
- Remote work arrangement
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