Director, Clinical Data Management & Digital Health Strategy

Merck; West Point (PA); Hybrid; USD 173,000 - 273,000; Full time

Job summary

Merck seeks a data management leader who sits at the intersection of strategy, innovation, and operational excellence to drive the vision for data management across a complex clinical portfolio.

This role leads vendor governance, KPIs, and talent development, aligning internal and external partners to deliver high-quality outcomes that advance scientific discovery, while steering continuous improvement and collaboration across BARDS, Regulatory, and GCTO.

Qualifications

• Bachelor's Degree or higher preferably in Medicine, Pharmacy, Nursing, Biological Sciences, Health Care, Computer Science or Engineering related discipline
• 12+ years of experience in Clinical Data Management and/or Clinical Operations (or related industry experience)
• 5+ years of experience in a management position
• 5+ years of experience with DHT, COA and/or IRT (Interactive Response Technologies) experience
• Have solid results and delivery-oriented leadership style with experience in best practice project management methods such as Waterfall and Agile
• Broad understanding of drug development - safety, clinical trials, trial design, data management, trial operations, regulatory, privacy, ICH, and GCP required
• Ability to manage a global organization with flexible staff through 3rd party partners
• Experience leading an organization that delivers against service level standards for all deliverables and services
• Experience working with internal and external stakeholders to deliver products and services supporting a portfolio of clinical trials/programs across multiple therapeutic areas
• Experience leading/sponsoring process and/or technology-based innovation initiatives to maximize delivery of services with measurable outcomes
• Must have excellent oral and written communications skills - able to present information confidentially and effectively to leadership, peers, and team.

Responsibilities

• Directs all data management support activities within their functional area.
• Aligns others around a positive direction and develops strategic plans with resource forecasts.
• Expert in vendors oversight and governance, interfacing with DHT/COA vendors to deliver high quality portfolios.
• Develops and tracks KPIs and leads vendor onboarding plans & activities; influences vendor QMS for quality outcomes.
• Develops career plans for direct reports, assigns work, conducts skill assessments, coaches for performance, and provides feedback.
• Provides developmental opportunities and training to employees, including growth assignments and mentoring.
• Provides advice on data management activities to internal and external clients.
• Directs staff in SOP development, implementation, and documentation to ensure regulatory compliance.
• May play a key role in selection of data management systems and work processes.
• May collaborate with data management groups from other divisions to ensure validity of data management techniques.
• Keeps abreast of new developments to guide tool/process maintenance.

Skills

Clinical Data Management

Data Validation

Decision Making

Digital Tech

GCDMP

GCP

People Leadership

Results Oriented

Strategic Thinking

Support Management

System Improvements

Vendor Management

Education

Bachelor's degree or higher

Job description

Merck seeks a data management leader who sits at the intersection of strategy, innovation, and operational excellence to drive the vision for data management across a complex clinical portfolio.

This role leads vendor governance, KPIs, and talent development, aligning internal and external partners to deliver high-quality outcomes that advance scientific discovery, while steering continuous improvement and collaboration across BARDS, Regulatory, and GCTO.