Rahway, New Jersey, United States
Hybrid
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 MentoringPreferred Skills:
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The salary range for this role is
$173,200.00 - $272,600.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this 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.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
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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Employee Status:
RegularRelocation:
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HybridShift:
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09/26/2026*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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