Why This Role MattersAs the Senior Manager, Clinical Operations- GI at Iterative Health 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 both internally and externally with a focus on improving research operations. Your day to day will include engaging with sponsors and CROs to report on study progress from site selection to close out. You are responsible for optimizing study performance through assessing gaps, identifying priorities for service(s) implementation and acting as a subject matter expert. This is a key, customer facing role responsible for providing clinical research best practices and thought leadership to our sites and sponsors. You will report to the Director, Clinical Operations and work closely with our Clinical Research and Life Science teams. Where You'll Drive Impact Study Activation Ownership & Execution- 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
Sponsor & CRO Partnership- 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 30%).
Study Performance & Operational Excellence- Monitor study performance metrics and own activation-specific reporting, including time-to-activation, SLA performance, and root causes of delays
- Analyze and provide feedback to sponsor/CRO on slower-than-expected enrollment, high screen fail rates, and/or 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.
- Performs related duties as requested
What You Bring to the Team - 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%.
Preferred Qualifications- 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 leadership, and executive stakeholders.
How We Work - Collaborative and low-ego team environment
- High ownership and accountability culture
- Fast-paced and highly iterative growth environment
- Open communication and continuous learning mindset
- Mission-driven organization focused on improving patient outcomes
- Comfortable navigating evolving business priorities and opportunities
Benefits That Support You We believe great teams do their best work when they feel supported - professionally and personally.
- 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
- And more!
New York pay range
$140,000-$165,000 USD
