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.

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…