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Evvy

At-home metagenomic vaginal microbiome sequencing

Study Manager

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeNew York, NY, USANo salary listed

About the Job

Requirements

  • 5–7 years coordinating clinical studies, with hands-on experience across multiple study types; diagnostic validation, observational, and interventional study experience is preferred.
  • Experience running multi-site studies or working with a contract research organization across multiple principal investigators and clinical sites, including optimizing workflows.
  • A strong point of view on how artificial intelligence can improve the speed and rigor of clinical research, with a track record of using it for protocols, site communications, and study reporting.
  • Experience in women's health, obstetrics and gynecology, fertility, or microbiome work, ideally with knowledge of relevant patients, providers, and clinical context.
  • Experience with institutional review board submissions, including WCG, Advarra, central, or local boards, and familiarity with electronic data capture platforms.
  • Working knowledge of International Council for Harmonisation Good Clinical Practice, Food and Drug Administration, and Health Insurance Portability and Accountability Act requirements.
  • Exceptional organization and documentation discipline.
  • Ability to keep principal investigators engaged, sites on track, finance informed, and leadership updated proactively.
  • Ability to move quickly and take full ownership of outcomes.

Responsibilities

  • Run and manage Evvy's portfolio of clinical studies end-to-end, owning timelines, milestones, and deliverables for each study.
  • Own principal investigator and site relationships; serve as Evvy's primary point of contact with principal investigators and clinical partner sites, maintaining engagement and momentum.
  • Manage study operations, ensuring each site has appropriate materials and shipping processes for sending samples to patients and returning them to the laboratory.
  • Co-lead site activation and management, including site selection, contracting, training, regulatory binders, monitoring visits, and close-out.
  • Manage institutional review board submissions and ongoing regulatory documentation, including initial submissions, amendments, continuing reviews, safety reporting, and audit readiness.
  • Maintain clinical documentation, including protocols, consent forms, source documents, electronic trial master files, and electronic data capture records, to standards suitable for Food and Drug Administration, institutional review board, or sponsor audits.
  • Partner with product and clinical teams on study design and the integration of clinical outputs into the product roadmap.
  • Report study progress to Evvy leadership regularly, including enrollment, milestones, risks, and decisions needed, to keep studies on time and on budget.
  • Build playbooks and systems that enable Evvy to run more studies as clinical operations scale.

Desired Qualifications

  • Certification as a Certified Clinical Research Coordinator, Certified Clinical Research Professional, or Association of Clinical Research Professionals certification.

About the Company

Evvy

At-home metagenomic vaginal microbiome sequencing

Evvy offers an at-home, CLIA- and CLEP-certified metagenomic sequencing test of the vaginal microbiome, with clinician review and personalized care pathways guided by EvvyAI. Tests are collected at home and sent to a lab, where results are interpreted by clinicians and translated into actionable guidance for patients through tailored care plans. The company differentiates itself by combining clinician-reviewed at-home testing, an AI advisor, and a growing body of peer-reviewed microbiome research and real-world data, including collaborations on fertility and IVF studies. Its goal is to close the gender health data gap by linking microbiome biology with symptoms, treatments, and outcomes to enable precision medicine in women's health.

Company size
51-200
Company stage
Series B
Total funding
$59M
Headquarters
New York City, New York
Founded
2020

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