Director, DHT Coordinator, GDMS Data Integration and Automation - Hybrid

The Director, Digital Health Technology (DHT) leads strategy and execution of DHT delivery across a Therapeutic Area, providing portfolio-level oversight and accountability for escalation management, and serving as a design authority. This role ensures TA-wide standards, consistent architectures, and end-to-end lifecycle management-from pre-production readiness through in-life change control to decommissioning-while maintaining compliance with GxP, Part 11, and departmental SOPs. Accountability includes high-impact deliverables, managing service provider performance, driving process optimization and technology enablement, and partnering with DI&A and data standards teams to align with enterprise strategy. Additionally, the position builds long-term capability through training, mentorship, and succession planning, while staying close enough to ensure operational excellence.

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.

Proactively identify risks, dependencies, and cross-functional impacts; recommend strategic mitigations that solve unique, complex problems with broad impact.

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.

Templates Composure Leadership Management Mentorship Governance Innovation Resilience Compassion Scalability Investments Adaptability Data Mapping Life Sciences Collaboration Accountability Change Control Data Integrity Clinical Trials Test Automation Data Management Post-Production Computer Science Telephone Skills Interoperability People Management Project Management Influencing Skills Acceptance Testing Exception Handling Succession Planning Service Improvement Contingent Workforce Lifecycle Management Process Optimization Technical Leadership Regulatory Compliance Escalation Management Stakeholder Management Operational Excellence Curriculum Development Pre-Clinical Development Clinical Data Management Software Design Patterns Organizational Performance Digital Health Technologies Equal Credit Opportunity Act Electronic Data Capture (EDC) Developing Training Materials Continuous Improvement Process Systems Development Life Cycle Performance Driving Techniques Software Development Life Cycle Milestones (Project Management) Key Performance Indicators (KPIs) Application Programming Interface (API)

At least 10 years, 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

Demonstrated ability to set TA-wide requirements for DHT configuration, integration, validation, and observability.

Soft skills:

Distill complex issues into decision-ready narratives; frame options, risks, and recommendations to influence senior decisions.

Strong influence skills and able to drive adoption of standardized methods/ways of working; mobilize cross-functional champions and measure uptake.

Align senior stakeholders on objectives, interfaces, and responsibilities; enforce clean handoffs and resolve conflicts.

Coordinate decisions across regions/time zones; use asynchronous mechanisms to maintain momentum.

Apply strong project management skills to drive on-time, high-quality delivery; lead technical team meetings, coordinate resources, and communicate status, risks, and mitigations to senior leadership.

Ability to evaluate platforms, build vs. buy, PoCs, performance/cost trade-offs at scale.

Ability to engage service provider, leadership, and industry forums; represent team professionally and credibly under pressure; maintain resilience and composure, * Bachelor’s Degree, preferably in life sciences, computer science, engineering or related discipline with a minimum of 10 years’ experience in eCOA/DHT or equivalent relevant industry experience, including:

• Demonstrate deep subject matter expertise
• People management skills

OR

• Advanced Degree (Masters or Doctorate), preferably in life sciences, computer science, engineering or related discipline with a minimum of 8 years’ experience in eCOA/DHT or equivalent relevant industry experience, including:

• Demonstrate deep subject matter expertise
• People management skills, Clinical Data Management, Clinical Development, Clinical Outcomes, Clinical Study Management, Data Integration, Regulatory Compliance, Software Development Life Cycle (SDLC), Stakeholder Management, System Validation, Technical Knowledge

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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The primary location for this posting is: USA - Pennsylvania - North Wales (Upper Gwynedd)

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is: $173,200.00 - $272,600.00

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.