Evvy

Evvy

Study Manager

New York City · Exec

Sponsorship not specifiedDetected 64 days ago
GCPComplianceCadenceHIPAAClinical TrialsClinical ResearchFDA RegulatoryResearchExperimental DesignLeadershipCommunicationCollaboration

About the role

  • 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.
  • Evvy is a primarily in-person team based in NYC.

Responsibilities

  • 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
  • Build the playbooks and systems that let Evvy run more studies, faster, as the clinical operation scales
  • Multi-site or CRO experience: you've run studies across multiple PIs and clinical sites and know how to optimize workflows
  • you move fast and own outcomes fully

Requirements

  • 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.

Nice to have

  • 5-7 years coordinating clinical studies, with hands-on experience across multiple study types (diagnostic validation, observational, and interventional preferred)
  • Strong working knowledge of ICH-GCP, FDA, and HIPAA requirements
  • CCRC, CCRP, or ACRP certification preferred

Compensation

  • 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.

Benefits

  • $1K learning and development budget
  • Health, dental, and vision insurance, plus HSA plans
  • Paid parental leave
  • Women's health, OB-GYN, fertility, or microbiome experience - ideally you understand the patients, the providers, and the clinical context

Visa & Work Authorization

  • entation airtight (protocols, consents, source documents, eTMF, and EDC) to a standard that holds up under FDA, IRB, or sponsor audit
Apply directly at Evvy →Create a free account for alerts like thisView Evvy immigration profile

This listing is sourced directly from Evvy's careers page and normalized into a canonical job model.