Senior Manager, Clinical Operations

Cambridge, Massachusetts, United States, New York, New York, United States

Iterative Health is a healthcare technology and services company that accelerates clinical research to transform patient outcomes. We operate a leading performance-driven network of over 100 sites across the US, Europe, India, and Australia, conducting research in gastrointestinal, hepatology, obesity, and cardiology. By combining deep clinical trial expertise with cutting‑edge AI, we connect sponsors’ scientific ambitions with high‑performing research teams to expedite and expand access to novel therapeutics.

You will serve as a strategic advisor to sponsors, CROs, and research sites, translating operational challenges into scalable solutions that improve study execution, accelerate activation timelines, and drive patient recruitment performance.

Your primary responsibility will be to engage with partners such as sponsors, CROs and key sites to drive executive operational alignment. You will provide strategic recommendations internally and externally to improve research operations, report on study progress from site selection to closeout, and act as a subject‑matter expert in optimizing study performance.

• Own the end‑to‑end site activations, managing timelines, dependencies, and risks across multiple concurrent sites and trials.
• Help teams prioritize tasks and ensure milestones are met within defined SLAs.
• Maintain activation plans, status tracking, and documentation; proactively escalating risks and delays.

• Serve as the primary operational partner to sponsors, CROs, and sites throughout the trial lifecycle.
• Lead and support sponsor, CRO, and partner meetings with operational expertise, actionable insights, and strategic recommendations.
• Build strong relationships with key stakeholders and ensure alignment on study goals, performance metrics, and operational priorities.
• Proactively communicate study risks, mitigation plans, and escalation strategies.
• Facilitate educational sessions, webinars, and customer forums to strengthen engagement and share best practices.
• Travel as needed to customer sites, investigator meetings, conferences, and sponsor engagements (up to 30%).

• Monitor study performance metrics and own activation‑specific reporting, including time‑to‑activation, SLA performance, and root causes of delays.
• Analyze and provide feedback on slower‑than‑expected enrollment, high screen fail rates, and variability in site performance.
• Use data to inform prioritization and process improvements.
• Identify operational gaps affecting site activation, enrollment, and execution, and collaborate cross‑functionally to address them.
• Advocate for site needs and serve as a subject‑matter expert in clinical research operations.
• Collaborate cross‑functionally to implement solutions that improve site performance and study outcomes.
• Partner with sponsors and CROs to streamline processes and optimize site activation timelines.
• Perform related duties as requested.

• Bachelor’s degree or equivalent combination of education and experience.
• 8+ years of experience supporting Phase II‑IV sponsor‑funded clinical trials.
• Deep understanding of clinical trial operations, including study startup, feasibility, regulatory processes, protocol execution, and GCP requirements.
• Experience working directly with sponsors, CROs, investigative sites, and cross‑functional stakeholders.
• Demonstrated ability to manage multiple priorities, navigate ambiguity, and drive projects to successful completion.
• Strong analytical, communication, and stakeholder management skills.
• Comfort adopting and leveraging new technologies and operational tools.
• Willingness to travel up to 30%.

• Experience in GI clinical research.
• Prior project or program management experience.
• 5+ years of experience as a Clinical Research Associate (CRA), or 3+ years leading clinical operations teams.
• Experience working in a high‑growth or startup environment.
• Experience presenting to sponsors, CRO…