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North Wales, Pennsylvania, United States
Hybrid
Job Description
Role Summary:
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.
Provide leadership for training and education for stakeholders; develop training materials and support onboarding and recognition programs.
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
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
Enterprise Leadership Skills:
Business Savviness | Anticipate business and regulatory issues and shape strategy accordingly; connect technical expertise to organizational and industry context to make strategic recommendations
Influence | Lead large teams / projects, help shape departmental strategy, influence leaders, peers, and cross-functional partners to align on decisions and strategic direction
Change Catalyst | Drive improvements (e.g., organizational and cultural changes) with broader impact; demonstrate adaptability and ability to collaborate with others to make change successful; help others overcome resistance to change
Qualifications & experience:
OR
clinicaltrialjobs
EligibleforERP
#GDMS
Required 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 KnowledgePreferred Skills:
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US and Puerto Rico Residents Only:
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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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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 - $272,600.00This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.
Additional location(s) Compensation Information:
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
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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.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
1st - DayValid Driving License:
NoHazardous Material(s):
N/AJob Posting End Date:
10/23/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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