Study Manager

ABOUT EVVY At Evvy, we believe the female body shouldn’t be a medical mystery. We are a precision women’s health company leveraging the vaginal microbiome to improve outcomes across a woman's lifespan. Backed by $60M+ from leading investors, we serve over 100,000 patients and 3,000 providers nationwide with our validated Vaginal Microbiome Test and AI-powered personalized care platform. Through this work, we have built the world’s largest dataset on the vaginal microbiome — a proprietary foundation that will drive breakthroughs in infertility, preterm birth, gynecological cancers, and beyond. Why join now? Evvy is a generational opportunity in women's health — and we're at the inflection point. - We’ve built a dataset no one has. Evvy has generated the world’s largest vaginal microbiome dataset from 100,000+ patients, uncovering novel biological markers underlying women’s health conditions that collectively cost the healthcare system $180B+ annually. - Validated, AI-first platform. We’ve built a comprehensive testing and care platform that unlocks personalized treatment pathways for each patient. Our work is supported by research published in major peer-reviewed journals and presented at major clinical conferences (including ACOG, ASRM, IDSOG, and more). - Proven traction, massive opportunity. We serve 100,000+ patients and 2,000 providers nationwide, with rapidly growing revenue and an expanding suite of diagnostics and treatments to improve outcomes across condition areas. We've only scratched the surface. - Top tier team, investors, and partners. Our world-class team is backed by industry leading investors, including General Catalyst, Left Lane Capital, US Fertility, and Labcorp. We're looking for high-horsepower, mission-driven people who find it unacceptable that the female body is still a medical mystery — and want to help change that. ABOUT THE ROLE We're looking for a Study Manager to run and manage Evvy's clinical study portfolio which includes both observational and interventional trials that generate the evidence behind our products. Reporting directly to the Co-founder & CSO, you'll be a critical hire on a small, high-leverage team, where the studies you run will directly shape what Evvy builds and launches. The best person for this job is an exceptional operator with experience overseeing multi-site studies in a fast-paced environment. That means owning studies end-to-end, from site activation and IRB submissions through enrollment, monitoring, and close-out. It also means serving as Evvy's primary point of contact for every principal investigator and clinical partner site we work with. Evvy is a primarily in-person team based in NYC. Our ideal candidate is located in NYC, with occasional travel to clinical partner sites. WHAT YOU'LL DO - Run and manage Evvy’s portfolio of clinical studies end-to-end (owning timelines, milestones, and deliverables across each) - Own the principal investigator and site relationships — serve as Evvy’s primary point of contact with PIs and clinical partner sites, keeping engagement high and the work moving - Manage operations for each study, ensuring each site has the right materials and shipping processes to get samples to patients and back to the lab. - Co-lead site activation and management: site selection, contracting, training, regulatory binders, monitoring visits, and close-out - Manage IRB submissions and ongoing regulatory documentation ( initial submissions, amendments, continuing reviews, safety reporting, and audit readiness) - Keep clinical documentation airtight (protocols, consents, source documents, eTMF, and EDC) to a standard that holds up under FDA, IRB, or sponsor audit - Partner product and clinical teams on study design and how clinical outputs flow into the roadmap - Report progress to Evvy leadership on a clear cadence (enrollment, milestones, risks, and decisions needed) so studies stay on time and on budget - Build the playbooks and systems that let Evvy run more studies, faster, as the clinical operation scales WHAT WE’RE LOOKING FOR - 5–7 years coordinating clinical studies, with hands-on experience across multiple study types (diagnostic validation, observational, and interventional preferred) - Multi-site or CRO experience: you’ve run studies across multiple PIs and clinical sites and know how to optimize workflows - A strong point of view on how AI can make clinical research faster and more rigorous, and a real track record of using it across protocols, site comms, and study reporting. - Women’s health, OB-GYN, fertility, or microbiome experience — ideally you understand the patients, the providers, and the clinical context - IRB submission experience (WCG, Advarra, central, or local) and familiarity with EDC platforms - Strong working knowledge of ICH-GCP, FDA, and HIPAA requirements; CCRC, CCRP, or ACRP certification preferred - Exceptional organization and documentation discipline - A genuine operator: you keep PIs engaged, sites on track, Evvy’s finance team informed, and leadership in the loop without needing to be asked - High agency: you move fast and own outcomes fully WORKING AT EVVY Evvy is a primarily in-person team based in New York, NY with a strong culture of collaboration and connection. We work from the office 4 days a week (Wednesdays remote), and we genuinely enjoy spending time together: team dinners, happy hours, and shared wins are part of the rhythm here. OUR VALUES Start with the why. We tie everything back to a user need or company goal. Figure it out. We take initiative, embrace ambiguity, and build from first principles. Create win-wins. We solve problems with patients, partners, and the business in mind. Own it to the end. We close every loop and take pride in the details. Stay eleven steps ahead. We anticipate, plan, and act with foresight and speed.     COMPANY BENEFITS - Competitive salary and equity package - Flexible PTO - $1K learning and development budget - Health, dental, and vision insurance, plus HSA plans - 401(k) plan (Roth and traditional) - Monthly team events - Free Evvy membership - Paid parental leave Evvy is an equal opportunity employer committed to diversity and inclusion. We welcome applicants of all backgrounds and do not discriminate based on race, gender, sexual orientation, age, disability, or other protected characteristics. All communications will come from an @evvy.com http://evvy.com email address.