About this role
Job Description
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.
Responsibilities
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.
Technical skills:
- 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.
Enterprise Leadership Skills:
- 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.
Qualifications & experience
- 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.
or
- 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.
clinicaltrialjobs
EligibleforERP
#GDMS
Required Skills:
Clinical Data Management, Coaching, Collaborative Leadership, Decision Making, Enterprise Leadership, Operational Excellence, People Leadership, Strategic Thinking, Team Mentoring, Team Organization
Preferred Skills:
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Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
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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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 salary range for this role is
$142,400.00 - $224,100.00
This 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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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:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
No
Job Posting End Date:
10/9/2026
*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.