Director, Program Lead – Clinical Data Management
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Job Description
Clinical data management program leader overseeing global clinical trial portfolios at Merck. Driving data quality, regulatory readiness, standards, resources, and cross-functional delivery.
Responsibilities:
- Lead program-level strategy and execution across multiple programs or therapeutic areas as the Global Clinical Data Management subject matter expert
- Oversee cross-program consistency, quality, and resource allocation
- Ensure adherence to team standards, data quality expectations, and regulatory requirements
- Provide leadership and direction to program teams; identify and mitigate operational risks
- Own program- and portfolio-level data management strategy and plans across eCRF, labs, biomarkers, PRO/eCOA, imaging, and other data modalities
- Lead risk-based planning, timelines, and inter-study dependencies across complex portfolios
- Govern consistent data collection, integration, validation, UAT, database lock, and inspection readiness across trials
- Drive quality, risk management, RCA/CAPA, audits, inspections, remediation, documentation, and archival
- Lead strategic initiatives in data standards, automation, digital enablement, and quality frameworks
- Represent Global Data Management & Standards in program- and portfolio-level forums
- Partner with Clinical, Biostatistics and Research Data Science, Data Integration and Automation, Safety, IT, service providers, Clinical Trial Operations, and Therapeutic Area leadership
- Act as escalation point for complex cross-functional and cross-program issues
- Support acquisitions and partnerships through data management due diligence and integration oversight
- Build organizational capability through mentoring, training, playbooks, and communities of practice
- Establish and use dashboards, KPIs, and analytics to guide execution oversight and service provider engagement
- Govern service provider performance, including SLAs, KPIs, QBRs, escalations, and remediation planning
- Set objectives, assign work, conduct reviews, coach employees, develop career plans, lead recruiting, manage employee relations, coordinate resources, manage budgets, facilitate meetings, and report to leadership
Requirements:
- Bachelor's degree 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
- Bachelor's degree or equivalent educational experience in any other field with a minimum of 15 years of experience in data management, clinical trial operations, or related field
- Advanced degree (Master's or Doctorate) in specified fields with 8 years of experience (preferred)
- Advanced degree (Master's or Doctorate) in any other field with a minimum of 13 years of experience
- Deep subject matter expertise and people management skills
- Experience leading geographically diverse cross-functional teams in clinical data management or clinical trial operations strategy, execution, and submissions
- Comprehensive knowledge of the clinical development lifecycle, end-to-end data flow, and cross-functional dependencies
- Experience leading end-to-end clinical trial data management, including database design and build, UAT, data validation and reconciliation, and database lock
- Experience managing complex portfolios, resource models, and multi-program delivery
- Proficiency with clinical data management platforms, EDC, eCOA, query management, reconciliation and integration workflows, and data visualization/dashboarding tools
- Understanding of data structures and integrations across EDC and connected systems including labs, IRT, eCOA, and imaging
- Advanced proficiency in CDISC, CDASH, SDTM, Define-XML, metadata management, controlled terminologies such as LOINC, and GDMS standards
- Knowledge of data quality frameworks, SOPs, ICH-GCP, 21 CFR Part 11/Annex 11, privacy requirements, and RBQM principles
- Expertise in operational metrics, analytics, and continuous improvement methodologies
- Travel: <=10%
Benefits:
- Remote work arrangement
- Regular employee status
- No relocation required
- No visa sponsorship required
- Travel requirement up to 10%
- Flexible work arrangements: Remote
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