Senior Manager, Clinical Operations

<div class="content-intro"><p></p> <p style="margin: 0in; font-family: 'Segoe UI'; font-size: 11.25pt; color: #242424;">Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes.</p> <p style="margin: 0in; font-family: 'Segoe UI'; font-size: 11.0pt; color: #242424;">&nbsp;</p> <p style="margin: 0in; font-family: 'Segoe UI'; font-size: 11.25pt; color: #242424;">We built a leading performance-driven network of 100+ sites across the US, Europe, India, and Australia, conducting research directly in the communities where care is delivered across 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 that expedite and expand access to novel therapeutics for patients in need.&nbsp;Today, Iterative Health is headquartered in Cambridge, Massachusetts, and New York City with 250+ employees world-wide.</p> <p></p></div><p><strong><span style="font-size: 10pt;">About Iterative Health&nbsp;</span></strong></p> <p><strong><span style="font-size: 10pt;">At<a href="https://iterative.health/?utm_source=chatgpt.com"> Iterative Health</a>, we are transforming clinical research through the power of AI, technology, and human expertise. Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to improve patient outcomes. Through the Iterative Health Site Network — a premier network of 100+ clinical research sites across the US and Europe — we help expand and expedite access to novel therapeutics for patients in need.</span></strong></p> <p><strong><span style="font-size: 10pt;">Why This Role Matters</span></strong></p> <p><strong><span style="font-size: 10pt;">As 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.&nbsp;</span></strong></p> <p><strong><span style="font-size: 10pt;">Your primary responsibility will be to engage with partners such as sponsors, CROs and key sites to drive executive operational alignment.&nbsp; 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.&nbsp;</span></strong></p> <p><strong><span style="font-size: 10pt;">This is a key, customer facing role responsible for providing clinical research best practices and thought leadership to our sites and sponsors. &nbsp;You will report to the Director, Clinical Operations and work closely with our Clinical Research and Life Science teams.&nbsp;</span></strong></p> <p><strong><span style="font-size: 10pt;">Where You’ll Drive Impact&nbsp;</span></strong></p> <p><strong><span style="font-size: 10pt;">Study Activation Ownership &amp; Execution</span></strong></p> <ul> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Own the end-to-end site activations, managing timelines, dependencies, and risks across multiple concurrent sites and trials</span></strong></li> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Help teams prioritize tasks and ensure milestones are met within defined SLAs</span></strong></li> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Maintain activation plans, status tracking, and documentation, escalating risks and delays proactively</span></strong></li> </ul> <h3><strong><span style="font-size: 10pt;">Sponsor &amp; CRO Partnership</span></strong></h3> <ul> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Serve as the primary operational partner to sponsors, CROs, and sites throughout the trial lifecycle.</span></strong></li> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Lead and support sponsor, CRO, and partner meetings by providing clinical operations expertise, actionable insights, and strategic recommendations.</span></strong></li> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Build strong relationships with key stakeholders and ensure alignment on study goals, performance metrics, and operational priorities.</span></strong></li> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Proactively communicate study risks, mitigation plans, and escalation strategies.</span></strong></li> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Facilitate educational sessions, webinars, and customer forums to strengthen engagement and share best practices.</span></strong></li> </ul> <ul> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Travel as needed to customer sites, investigator meetings, conferences, and sponsor engagements (up to 30%).</span></strong></li> </ul> <h3><strong><span style="font-size: 10pt;">Study Performance &amp; Operational Excellence</span></strong></h3> <ul> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Monitor study performance metrics and own activation-specific reporting, including time-to-activation, SLA performance, and root causes of delays</span></strong></li> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Analyze and provide feedback to sponsor/CRO on slower-than-expected enrollment, high screen fail rates, and/or variability in site performance</span></strong></li> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Use data to inform prioritization and process improvements</span></strong></li> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Identify operational gaps affecting site activation, enrollment, and execution, and collaborate cross-functionally to address them</span></strong></li> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Advocate for site needs and serve as a subject matter expert in clinical research operations</span></strong></li> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Collaborate cross-functionally to implement solutions that improve site performance and study outcomes.</span></strong></li> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Partner with sponsors and CROs to streamline processes and optimize site activation timelines.</span></strong></li> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Performs related duties as requested&nbsp;</span></strong></li> </ul> <p><strong><span style="font-size: 10pt;">What You Bring to the Team&nbsp;</span></strong></p> <ul> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Bachelor's degree or equivalent combination of education and experience.</span></strong></li> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">8+ years of experience supporting Phase II-IV sponsor-funded clinical trials.</span></strong></li> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Deep understanding of clinical trial operations, including study startup, feasibility, regulatory processes, protocol execution, and GCP requirements.</span></strong></li> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Experience working directly with sponsors, CROs, investigative sites, and cross-functional stakeholders.</span></strong></li> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Demonstrated ability to manage multiple priorities, navigate ambiguity, and drive projects to successful completion.</span></strong></li> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Strong analytical, communication, and stakeholder management skills.</span></strong></li> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Comfort adopting and leveraging new technologies and operational tools.</span></strong></li> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Willingness to travel up to 30%.</span></strong></li> </ul> <h3><strong><span style="font-size: 10pt;">Preferred Qualifications</span></strong></h3> <ul> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Experience in GI clinical research</span></strong></li> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Prior project or program management experience.</span></strong></li> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">5+ years of experience as a Clinical Research Associate (CRA) , or 3+ years leading clinical operations teams.</span></strong></li> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Experience working in a high-growth or startup environment.</span></strong></li> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Experience presenting to sponsors, CRO leadership, and executive stakeholders.</span></strong></li> </ul> <p><strong><span style="font-size: 10pt;">How We Work&nbsp;</span></strong></p> <ul> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Collaborative and low-ego team environment</span></strong></li> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">High ownership and accountability culture</span></strong></li> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Fast-paced and highly iterative growth environment</span></strong></li> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Open communication and continuous learning mindset</span></strong></li> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Mission-driven organization focused on improving patient outcomes</span></strong></li> <li style="font-size: 10pt; font-weight: bold;"><strong><span style="font-size: 10pt;">Comfortable navigating evolving business priorities and opportunities</span></strong></li> </ul> <p><br><strong><span style="font-size: 10pt;">Benefits That Support You&nbsp;</span></strong></p> <p><span style="font-size: 10pt;">We believe great teams do their best work when they feel supported — professionally and personally.</span></p> <ul> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Hybrid work environment with in-office collaboration two days per week in either our NYC or Boston office</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Comprehensive medical, dental, and vision coverage, with up to 80% of premiums covered by Iterative Health</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Mental health and wellness support through Spring Health</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Health HSA or FSA options, and commuter FSA contributions supported by Iterative Health</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Unlimited PTO, 12 company holidays, and a company-wide shutdown between Christmas and New Years</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">401(k) program with a company match of up to 3% (up to $3,000 annually)</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Weekly in-office lunch benefit every Tuesday</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">100% company-paid short-term and long-term disability coverage</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Annual wellness and professional development stipend to support your health and growth</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">And more!</span></li> </ul><div class="content-pay-transparency"><div class="pay-input"><div class="title">New York pay range</div><div class="pay-range"><span>$140,000</span><span class="divider">&mdash;</span><span>$165,000 USD</span></div></div></div><div class="content-conclusion"><p>At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.</p></div>