Senior Study Integration Leader | CDM & eCRF Programs

MSD Malaysia; Rahway (NJ); Hybrid; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision healthcare and other insurance

401(k) retirement benefits

Paid holidays

Vacation

Compassionate and sick days

Job summary

Merck & Co., Inc. in Rahway, NJ, USA, a global healthcare leader, seeks an Associate Director, Study Integration Manager to lead a team delivering trial-level technical data-management components (eCRFs, integrations, edit checks, reports) with quality and compliance to GDMS/DI&A standards.

The role acts as a hands-on coach and reviewer, balancing workload, ensuring documentation, validation, and change control are audit-ready, and partnering with Clinical, BARDS, DI&A/IT, service providers, and

Qualifications

• Bachelors Degree with a minimum of 8 years experience working in relevant field for associated job description, including: 2 years people management experience.
• 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.

Responsibilities

• Lead study-level design/build/test/release; author/peer-review specs (eCRF, edit checks, mappings).
• Cross-functional program planning & governance; synchronize release calendars, risks and change control.
• Maintain program RAID logs; lead risk mitigation and CAPA; ensure CSV/GxP validation evidence and inspection readiness.
• Partner with functional leads to secure resources; manage service provider SOWs/SLAs and performance.
• Coach, mentor, and develop capability across the team; drive continuous improvement.

Skills

Execution Excellence

Coaching & Development

Entrepreneurship

Education

Bachelor's degree in relevant field

Advanced degree (Masters or Doctorate)

Tools

Jira/Confluence/Smartsheet

Job description

Merck & Co., Inc. in Rahway, NJ, USA, a global healthcare leader, seeks an Associate Director, Study Integration Manager to lead a team delivering trial-level technical data-management components (eCRFs, integrations, edit checks, reports) with quality and compliance to GDMS/DI&A standards.

The role acts as a hands-on coach and reviewer, balancing workload, ensuring documentation, validation, and change control are audit-ready, and partnering with Clinical, BARDS, DI&A/IT, service providers, and