Director, Clinical Data Management - Hybrid

Merck; West Point (PA); On-site; USD 180,000 - 280,000; Full time

Job summary

Merck seeks a Director, Study Integration Manager to lead a team and oversee study-integration delivery across programs and regions. This role acts as senior technical authority, approving high-impact designs, governing standards at scale, balancing demand and capacity, and driving automation and operational excellence.

You will mentor staff, coordinate cross-functional teams, manage budgets, and communicate status to sponsors and governance forums.

Qualifications

• Minimum 10+ years in clinical data management or a related field.
• Bachelor’s degree required; advanced degree preferred.
• Strong leadership and program management experience in multi-site trials.

Responsibilities

• Lead study technical planning and delivery from design through closeout.
• Coordinate cross-functional teams; manage risks and governance.
• Ensure audit-ready documentation and validation patterns.
• Mentor junior staff; drive automation and CI/CD in validated contexts.
• Communicate status and decisions to sponsors and governance forums.

Skills

Leadership

Clinical Data Management

Program Management

Cross-functional Collaboration

Risk Management

Agile / Lean

Coaching & Mentoring

Data Architecture

Automation

Education

Bachelor’s Degree

Advanced Degree (Masters or Doctorate)

Tools

CDM systems

CSV/Data validation

Job description

Job Description

Job Description

The Director, Study Integration Manager leads a team and has portfolio-level oversight of study-integration delivery across programs and regions. This Director serves as senior technical authority—approving high-impact designs, governing standards at scale, balancing demand vs. capacity, and driving automation and operational excellence—while remaining close to the work through targeted reviews and coaching. Represents the function in internal/external forums and ensures consistent, audit-ready outcomes.

Responsibilities:

Study technical planning & delivery

• Own the integrated plan from design through closeout across in-scope studies; synchronize releases and dependencies.
• Ensure all technical components are production-ready before first-patient-first-visit; monitor status/quality pre- and post-release.
• Oversee decommissioning and archival with complete, audit-ready documentation.
• Directly lead critical or high-risk studies or cross-program integrations to unblock delivery and model best practices.
  
  

Cross-functional coordination, risks & governance

• Set the program/TA technical strategy aligned to GDMS/DI&A goals; translate business objectives into executable technical roadmaps and outcomes.
• Participate as needed on the DI&A governance team; present decision-ready recommendations and trade-offs.
• Define and manage SOWs/SLAs/SLOs; track service provider delivery health and hold partners accountable for quality and timelines.
• Champion risk-based computer system validation (CSV) and inspection readiness in partnership with cross-functional teams.
• Coordinate internal audits (point of contact), including evidence, responses, and action plans.
• Communicate status, risks, and decisions to sponsors and governance forums with clear escalation paths.
• Build business cases and prioritize initiatives; define OKRs/KPIs and dashboards (quality, cycle time, cost, stability) and track value realized.
  
  

Standards, quality & continuous improvement

• Act as design authority for data collection/flows, integrations, and validation patterns; arbitrate configure vs. customize decisions.
• Drive design consistency based on global and TA standards in all key deliverables part of clinical data management system.
• Provide technical consultancy on data architecture, metadata, and cross-system interoperability
• Mentor and coach junior team members; review plans/specs, uplift practices (agile, testing, automation), and create learning opportunities.
• Foster experiment/test-and-learn culture; sponsor communities of practice and reusable assets/templates.
• Lead strategic improvement initiatives (automation, CI/CD in validated contexts, test efficiency, MDR/metadata enablement), including introduction of new processes / technologies
  
  

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.
• Inspire and ensure that team leaders are effectively supporting and empowering their individual leaders.
  
  

Technical Skills

• Demonstrated ability to review and approve complex designs and integration patterns; optimize mappings, error handling, and data lineage.
• Deep knowledge of data capture, aggregation, consumption, and flow.
• Ability to independently lead study-level design/build/test/release; author/peer-review specs (eCRF, edit checks, mappings).
• Strong hands-on with clinical data management (CDM) systems; working proficiency across multi-system data flows and API-based or file integrations.
• Understanding of clinical, data, and sponsor standards.
  
  

Non-technical Skills

• Distills complex issues into decision-ready narratives; frames options, risks, and recommendations to influence senior decisions
• Drives adoption of standardized methods/ways of working; mobilizes cross-functional champions and measures uptake
• Aligns senior stakeholders on objectives, interfaces, and responsibilities; enforces clean handoffs and resolves conflicts
• Ability to coordinate decisions across regions/time zones; uses asynchronous mechanisms to maintain momentum
• Engages service provider, leadership, and industry forums; represents team professionally and credibly under pressure; maintains resilience and composure
• Ability to define and execute organizational strategy for operations across regions
• Demonstrated success managing large, and geographically distributed teams
• Strong understanding of operational, financial, and compliance dimensions of global data delivery
• Capable of leading transformation initiatives and fostering innovation across complex organizations
• Excellent communicator with the ability to translate technical and operational priorities into clear, actionable direction
• Leads through influence across functions/geographies; mentors global cohorts; provides structured feedback
• Enterprise Leadership Skills.
  
  

Strategic Planning | Plans strategically by gathering information and identifying key issues, dependencies, and relationships critical to achieving long-range goals; commits to a course of action after developing and evaluating alternatives based on facts, available resources, constraints, and organizational values.

Networking & Partnerships | Cultivates networks and partnerships by initiating and maintaining strategic relationships with stakeholders and potential partners inside and outside the organization who provide the information, ideas, expertise, and influence needed to deepen understanding of business issues and achieve business goals.

Change Catalyst | Leads change by driving the organizational and cultural shifts needed to achieve strategic priorities; catalyzes new approaches to improve results by evolving culture, systems, and services; helps others overcome resistance and adopt change.

Qualifications & Experience:

Bachelor’s Degree with a minimum of 10 year's experience working in relevant field for associated job description, including:

• 3 years people management experience.
• Demonstrated deep subject matter expertise in relevant discipline
  
  

OR

Advanced Degree (Masters Or Doctorate) With a Minimum Of 8 Year's Experience Working In Relevant Field For Associated Job Description, Including:

• 3 years people management experience.
• Demonstrated deep subject matter expertise in relevant discipline
  
  

clinicaltrialjobs

EligibleforERP

#GDMS

Required Skills:

Adaptability, Audit Trails, Career Planning, Change Management, Clinical Data Management, Collaborative Leadership, Decision Making, Planning, Strategic Alignment, Strategic Planning, Strategic Thinking, Team Mentoring

Preferred Skills:

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