Study Manager

Evvy•New York, NY

8d•Hybrid

About The Position

Evvy is seeking a Study Manager to oversee and manage its clinical study portfolio, which includes both observational and interventional trials. This role is crucial for generating evidence behind Evvy's products and will directly influence the company's future development and launches. The ideal candidate is a highly capable operator experienced in managing multi-site studies in a dynamic environment, responsible for all aspects of study management from initiation to completion, and serving as the main liaison with principal investigators and clinical partner sites.

Requirements

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

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
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