Senior Manager, Clinical Operations - GI
About The Position
Iterative Health is a healthcare technology and services company focused on accelerating clinical research to improve patient outcomes. They operate a network of over 100 research sites globally, specializing in gastrointestinal, hepatology, obesity, and cardiology. By integrating clinical trial expertise with AI, Iterative Health connects sponsors with high-performing research teams to expedite access to new therapies. The company is headquartered in Cambridge, Massachusetts, and New York City, with over 250 employees worldwide. As the Senior Manager, Clinical Operations- GI, you will act as a strategic advisor, translating operational challenges into scalable solutions to enhance study execution, speed up activation timelines, and boost patient recruitment. This role involves strengthening sponsor relationships, improving site performance, and contributing to Iterative Health's mission. The position is central to ensuring efficient study launches, successful site setups, and providing sponsors with the necessary insights and partnership to meet their clinical development objectives. A key responsibility will be scaling the site activation process across the organization, ensuring on-time activations within SLAs, proactively resolving blockers, and refining workflows for increased speed, predictability, and efficiency. This is a highly visible, customer-facing role with the opportunity to influence study strategy, shape operational best practices, and drive significant impact across a growing portfolio of clinical trials.
Requirements
- 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%.
Nice To Haves
- Experience in cardiology clinical research.
- Prior project or program management experience.
- 5+ years of experience as a Clinical Research Associate (CRA) or Clinical Research Coordinator (CRC), or 3+ years leading clinical operations teams.
- Experience with CTMS platforms, with RealTime CTMS strongly preferred.
- Experience working in a high-growth or startup environment.
- Experience presenting to sponsors, CRO leadership, and executive stakeholders.
Responsibilities
- 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, escalating risks and delays proactively
- Serve as the primary operational partner to sponsors, CROs, and sites throughout the trial lifecycle
- Lead and support sponsor, CRO, and partner meetings by providing clinical operations 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 15%)
- Monitor study performance metrics and own activation-specific reporting, including time-to-activation, SLA performance, and root causes of delays
- Build and maintain dashboards that provide clear stakeholder visibility
- Use data to inform prioritization, process improvements, and resourcing decisions
- 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
- Performs related duties as requested
Benefits
- Hybrid work environment with in-office collaboration two days per week in either our NYC or Boston office
- Comprehensive medical, dental, and vision coverage, with up to 80% of premiums covered by Iterative Health
- Mental health and wellness support through Spring Health
- Health HSA or FSA options, and commuter FSA contributions supported by Iterative Health
- Unlimited PTO, 12 company holidays, and a company-wide shutdown between Christmas and New Years
- 401(k) program with a company match of up to 3% (up to $3,000 annually)
- Weekly in-office lunch benefit every Tuesday
- 100% company-paid short-term and long-term disability coverage
- Annual wellness and professional development stipend to support your health and growth
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What This Job Offers
Job Type
Full-time
Career Level
Senior
