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 $30M+ from leading investors, we serve over 100,000 patients and 2,000 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.

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.

• Owning studies end-to-end, from site activation and IRB submissions through enrollment, monitoring, and close-out
• Serving as Evvy's primary point of contact for every principal investigator and clinical partner site we work with
• Managing 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
• Managing IRB submissions and ongoing regulatory documentation (initial submissions, amendments, continuing reviews, safety reporting, and audit readiness)
• Keeping clinical documentation airtight (protocols, consents, source documents, eTMF, and EDC) to a standard that holds up under FDA, IRB, or sponsor audit
• Partnering product and clinical teams on study design and how clinical outputs flow into the roadmap
• Reporting progress to Evvy leadership on a clear cadence (enrollment, milestones, risks, and decisions needed) so studies stay on time and on budget
• Building the playbooks and systems that let Evvy run more studies, faster, as the clinical operation scales

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

Company Benefits

• 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

Company Values

• Start with the why
• Figure it out
• Create win-wins
• Own it to the end
• Stay eleven steps ahead