Director, Program Lead – Clinical Data Management

🔥 0 minutes ago

🌐 United States, Argentina, +3 more countries – Remote

🇺🇸 United States – Remote 🇦🇷 Argentina – Remote 🇨🇴 Colombia – Remote 🇨🇷 Costa Rica – Remote 🇵🇱 Poland – Remote

🏖️ New Jersey, Pennsylvania – Remote

🏖️ New Jersey – Remote 🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

📋 Program Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

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MSD

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1891

🏥 Healthcare

📦 Logistics

🧬 Biotechnology

Healthcare • Logistics • Biotechnology

MSD is a leading biopharmaceutical company known as Merck & Co. , Inc. in the United States, Canada, and Puerto Rico, and as MSD globally. The company focuses on scientific innovation to deliver medicines and vaccines for various health challenges, including oncology, vaccines, infectious diseases, and cardio-metabolic diseases. MSD operates multiple divisions, including Human Health, Animal Health, and Research & Development. With approximately 75,000 employees worldwide and a significant investment in research and development, MSD is committed to improving global health through its scientific advancements. Additionally, the company places a strong emphasis on diversity, inclusion, and corporate responsibility. MSD’s operations extend worldwide, offering opportunities in numerous regions and promoting diversity and innovation in all aspects of its business.

📋 Description

• 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