Associate Director - Study Integration Manager, Data Integration and Automation - Hybrid

The Associate Director, Study Integration Manager (M-track) leads a team to deliver trial-level technical data-management components (eCRFs, integrations, edit checks, reports) with quality and compliance to GDMS/DI&A standards. This individual acts as a hands-on coach and technical reviewer by balancing workload, unblocking issues, and ensuring that documentation, validation, and change control are audit ready. The Associate Director, Study Integration Manager partners closely with Clinical, BARDS, DI&A/IT, service providers, and other stakeholders to drive on-time, inspection-ready delivery., Study technical planning & delivery:

• Build and maintain the integrated program plan from design through close-out across all in-scope trials.
• Drive program-level consistency in study-level technical deliverables.
• Ensure all technical components are production-ready before first-patient-first-visit; monitor status/quality pre- and post-release; support end-of-study archival and decommissioning.
• When needed, directly lead one or more complex trials as Study Integration Manager.

Cross-functional coordination, risk & governance:

• Synchronize release calendars, dependencies, and change control; chair/participate in program change/governance meetings.
• Plans across studies; runs risk/change control; aligns stakeholders; provides reliable status reporting and governance updates.
• Maintain program RAID logs; lead risk mitigation and CAPA; ensure CSV/GxP validation evidence and inspection readiness; support/lead audits including appropriate documentation.
• Partner with functional leads to secure/align resources; manage service provider SOWs/SLAs and performance; track delivery health and value.
• Serve as the program point of contact for technical components; manage expectations; provide clear, decision-ready status to sponsors/steering.

Standards, quality & continuous improvement:

• Identify and lead process/tool improvements (automation, test efficiency, templates); capture lessons learned; contribute to SOP/WI updates.
• Guide and review SIM plans/specs; coach, mentor, and develop capability across the team.
• Steward standards and change requests; arbitrate configuration vs. customization; ensure alignment with database/clinical standards.

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 individual leaders., * Execution Excellence

  Is results-focused per compliance standards; sets ambitious expectations for accomplishment and ensures others contribute to org strategies by focusing them on the most critical priorities; translates departmental goals into clear expectations.

• Coaching & Development

  Manages individual contributors and/or supervisors, provides technical guidance, and develops others through coaching, feedback, and guidance.

• Entrepreneurship

  Embraces patient customer focus, ensuring that internal or external customer perspective is the driving force behind strategic priorities, business decisions, org processes, and individual activities; crafts and implements service practices that meet customers’ and own organization needs.

• 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) lifecycle; working proficiency across multi-system data flows and API-based or file integrations.
• Understanding of various clinical, data, and sponsor standards.
• Experience with work tracking programs (e.g., Jira/Confluence/Smartsheet); exposure to automation (templated checks, reusable specs), and monitoring (listings/dashboards).

Non-technical skills:

• Strong communication and negotiation skills, with ability to craft concise, decision-ready summaries and narratives for leadership and frames risks, options, and recommendations.
• Aligns priorities with service providers and cross-functional leaders; manages escalations.
• Able to operate effectively in ambiguity; drives consensus across functions; steers process/technology improvements.
• Engages service provider, leadership, and industry forums; represents team professionally and credibly under pressure; maintains resilience and composure.
• Strong ability to lead teams in a matrixed, global organization while ensuring delivery excellence.
• Demonstrated success in coaching, developing, and performance-managing high-performing individuals.
• Builds strong partnerships across technical, business, and quality functions to enhance collaboration and deliver integrated outcomes.
• Balances business needs, resource capacity, and compliance requirements to make sound operational decisions.
• Capable of leading teams through process and organizational transformation with empathy and clarity.
• Guides and reviews work across teams/geographies; builds capability and consistency; fosters inclusive, high-trust culture., * Bachelors Degree with a minimum of 8 years experience working in relevant field for associated job description, including:
• 2 years people management experience.
• Demonstrated deep subject matter expertise in relevant discipline., * Advanced Degree (Masters or Doctorate) with a minimum of 4 years experience working in relevant field for associated job description, including:
• 2 years people management experience.
• Demonstrated deep subject matter expertise in relevant discipline., Clinical Data Management, Coaching, Collaborative Leadership, Decision Making, Enterprise Leadership, Operational Excellence, People Leadership, Strategic Thinking, Team Mentoring, Team Organization

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.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

The salary range for this role is

$142,400.00 - $224,100.00

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.