Associate Director, Clinical Operations

Role Overview

This position calls for an experienced clinical operations leader to manage studies across the full lifecycle, from start-up through study closeout. The role is centered on coordinating trial execution, maintaining timelines and budgets, and ensuring that programs stay compliant, efficient, and inspection-ready.

What You Will Do

• Direct the full management of clinical trials across Phase I to Phase IV, including start-up, execution, and closeout.
• Build and maintain project schedules and budgets, and handle monthly invoice checks and reconciliation.
• Lead site identification, site activation, ongoing monitoring, and final closeout activities.
• Track study execution closely so milestones are delivered on schedule and within scope.
• Act as the main point of contact for CROs, vendors, and other external collaborators.
• Spot potential program risks early and put practical mitigation plans in place.
• Make sure all study activities follow applicable standards and regulations, including GCP, ICH, and internal SOPs.
• Review study performance indicators and share regular progress updates with senior leadership.
• Evaluate and sign off on key trial documents such as monitoring plans, subject recruitment plans, and study reports.
• Help maintain inspection readiness and support audits when required.
• Coach and guide junior project managers and clinical operations team members.
• Support the creation of site-level subject recruitment strategies.
• Take part in peer review of SOPs and Work Instructions.

Required Background

The role requires a bachelor’s degree in Life Sciences, Nursing, or a related discipline, with an advanced degree considered an advantage. Candidates should bring 8 to 12+ years of clinical research experience, including managing US, global, and multi-center trials. The position is based in the US, and the candidate must be able to travel to clinical sites internationally and work East Coast hours. Strong knowledge of ICH, GCP, FDA, and broader clinical trial regulatory expectations is essential. The ideal candidate will have a track record of leading complex projects, working across functions, solving problems effectively, and influencing stakeholders through clear communication and sound judgment.

Additional Information

This is a full-time onsite role with Genepool Networks in the Greater Boston area. The position requires independent working capability as well as strong collaboration across teams. No salary, number of openings, or start date was specified in the source details.