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

HireLifeScience

Rahway (NJ)

On-site

USD 120,000 - 180,000

Full time

3 days ago
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Job summary

HireLifeScience seeks an Associate Director, Study Integration Manager (M-track) to lead a team delivering trial-level data-management components (eCRFs, integrations, edit checks, reports) with quality and compliance to GDMS/DI&A standards. The role acts as hands-on coach and technical reviewer, balancing workload and ensuring audit readiness of documentation, validation, and change control.

You will partner with Clinical, BARDS, DI&A/IT, service providers, and stakeholders to ensure on-time,

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.

Job description

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.
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