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Merck

Director, Digital Health Technology Services, GDMS Data Integration and Automation - Hybrid

Location
(Multi-state)
Posted
Posted today (employer shows the date only)
Source
Workday (employer's applicant tracking system)
Category
Engineering/Technology
Industry
Pharma/Biotech
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Job Description

The Director, Digital Health Technology (DHT) Services provides multi-team, multi-region leadership and portfolio-level oversight of DHT delivery. This Director approves high-impact designs, balances demand vs. capacity across programs and suppliers, scales automation and best practices, builds long-term capability, represents DHT in governance forums, manages Service Provider performance and escalations, and ensures succession planning within the DHT pillar.

Responsibilities:

DHT System delivery & study execution

  • Accountable for portfolio and programs SDLC delivery anticipating regulatory/compliance risks and driving product, process, and service improvements while ensuring consistency, scalability, and compliance (GxP, Part 11, Departmental SOPs).
  • Oversee full lifecycle management across TA portfolio, including pre-production readiness, post-production monitoring, change control, and timely decommissioning/archival with audit-ready documentation.
  • Hold Service Providers accountable for quality and innovation to achieve strategic milestones and objectives; ensure service levels are met or exceeded.
  • Build collaborative relationships and take a leadership role to align Service Providers and internal stakeholders on fit-for-purpose solutions tied to study and portfolio milestones, contributing to departmental strategy execution.
  • Provide oversight for end-to-end delivery of complex data-management activities across multiple studies and systems, anticipating regulatory/compliance issues and solving unique challenges with broad business impact.
  • Contribute to and shape departmental strategy by initiating and leading high-impact projects and initiatives.

Data integration, quality & system operations:

  • Oversight of end-to-end data integrity and compliance across all studies and systems, proactively identifying internal/external risks and recommending improvements.
  • Monitor data integrations and quality, ensuring robust interoperability (APIs, files, schedules), resiliency, and error handling; anticipate systemic issues; support defect triage and drive timely resolution.
  • Provide technical leadership, guidance, and reviews; advise on design trade-offs and complex data mapping/reporting/archiving.

Governance, compliance & continuous improvement:

  • Contribute to departmental strategy by establishing and scaling TA-level standards, templates, and design patterns for DHT setup, flows, and reporting that improve products, processes, and services.
  • Represent DHT in governance and leadership and industry forums, anticipate emerging business and regulatory issues, and recommend strategic actions.
  • Drive process optimization and technology enablement; identify and implement improvements (templates, test automation, dashboards); scale best practices and tools.
  • Partner with DI&A and data standards teams on roadmaps and alignment to enterprise data strategy.
  • Lead adoption and change across Service Providers and internal stakeholders to standardize DHT systems, acting as facilitator and mentor to empower others.
  • Anticipate and prepare for regulatory inspections and audits, leading readiness with expert guidance.
  • Define OKRs/KPIs; report organizational performance, risks, and investment needs; recommend data-driven actions to leadership.
  • Ensure maintenance of SOPs, reference documents, and execution resources relevant to DHT setup and operations.
  • Lead capability building: define curricula, mentorship models, and competency frameworks; champion knowledge sharing and communities of practice; provide input into succession planning.
  • Provide leadership for training and education for stakeholders, develop training materials, and support onboarding and recognition programs.

People Management:

  • Align teams around a clear direction; set clear objectives aligned to organizational goals; assign work and set priorities accounting for work-life balance sustainability.
  • 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 and oversee performance management activities, including management of sensitive employee-relations matters in partnership with HR.
  • Coordinate on-shore/off-shore and contingent resources; ensure role clarity and effective handoffs.
  • Manage an operating budget and optimize spend against priorities.
  • Inspires and ensures that team leaders are effectively supporting and empowering their team members.

Technical skills:

  • Advanced expertise with electronic Clinical Outcome Assessment (eCOA) or Digital Health Technology (DHT) platforms used in clinical trials
  • Expert-level knowledge of the clinical development process, DHT, electronic data capture, preferably through submission; thorough knowledge of clinical data management.
  • Advanced understanding of UAT processes, system validation, and regulatory compliance requirements for clinical data systems

…

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