Senior Clinical Trial Manager
RegCell · San Francisco Bay Area
Apply & track with Apply EdgeThis is a rare opportunity to join a company at its foundation and play a hands-on role in bringing our first programs into the clinic.Position SummaryRegCell is seeking a Senior Clinical Trial Manager to manage the day-to-day execution of RC-101. Reporting to the Head of Clinical Operations, this person will keep the study moving from start-up through enrollment, conduct, and closeout.This is an execution-focused role for someone who thrives on detail: drafting site manuals, tracking site activation, chasing contracts and budgets, following up on monitoring findings, and troubleshooting cell product shipments. You will be the primary day-to-day contact for the CRO, clinical sites, and study vendors, and will work closely with colleagues in CMC/manufacturing, quality, and regulatory. By owning the operational delivery of RC-101.Because every person on a small team shapes how we work together, we place as much weight on how you collaborate as on what you deliver.Key ResponsibilitiesDay-to-day study managementManage the day-to-day execution of RC-101, keeping the study on track against timelines, budget, and quality standards.Drive study start-up activities, including site feasibility and selection, site contracts and budgets, regulatory and ethics submission packages, essential document collection, and site activation.Maintain study trackers for site activation, enrollment, patient visits, and deliverables; identify issues early and bring them to the Head of Clinical Operations with proposed solutions.Work hands-on with sites to support patient screening and enrollment, and resolve site questions and issues quickly.Coordinate cell therapy logistics with CMC, quality, and supply chain, including chain of identity, product scheduling, shipment, and site readiness.Conduct in-house data review, drive query resolution, and support database lock and study closeout.CRO, vendor, and site managementServe as the day-to-day sponsor contact for the CRO and study vendors (e.g., central and specialty labs, EDC/IRT, couriers); run regular operational meetings and track action items to closure.Review monitoring visit reports (SIV, IMV, COV), follow up on findings, and confirm issues are resolved; conduct sponsor visits as needed (up to approximately 20% travel).Review vendor and site invoices against contracts and track study spend.Train site staff on the protocol and study procedures, and build strong working relationships with investigators and study coordinators.Study documents and compliancePrepare and maintain study plans, manuals, and site-facing materials (e.g., pharmacy and product handling manual, lab manual, ICF templates), and contribute to the protocol, CRFs, and CSR.Support user acceptance testing of EDC, IRT, and other study systems.Maintain an inspection-ready TMF and ensure study conduct complies with GCP, ICH, FDA, and applicable regulations.Use and refine study-level templates, trackers, and work instructions as needed.Required QualificationsMinimum of 5 years of hands-on clinical trial management experience at a sponsor or CRO, including day-to-day management of at least one study through start-up and into enrollment.A track record of executing studies directly (site activation, vendor management, monitoring follow-up, TMF), not only overseeing the work of others.Experience with early-phase (Phase 1 or 1/2) studies.Thorough knowledge of GCP, ICH, FDA, and applicable global regulatory requirements, and of clinical trial medical terminology.Highly organized and detail-oriented, with the ability to manage many moving parts and shifting priorities.Clear, concise written and verbal communication skills.Proven ability to build productive relationships with investigators, site staff, CROs, vendors, and internal colleagues.Able and willing to travel domestically (approximately 20%).PreferredExperience in cell therapy (e.g., Treg, CAR-T, CAR-NK, or other engineered or autologous/allogeneic cell products), including cell product logistics and chain of identity management.Experience in autoimmune, immunology, or hepatology indications.Experience at a small or early-stage biotech, serving as the primary operational contact for a study.Experience with first-in-human studies and investigator-initiated or academic site networks.Who will thrive hereSomeone who enjoys being in the details and takes pride in getting things done, from tracking down a missing regulatory document to resolving a site issue the same day.A self-starter comfortable in a fast-paced start-up environment, who takes ownership of tasks without waiting for direction.A pragmatic, solution-focused operator who can balance quality and compliance with speed and resourcefulness.A genuine team player who leads with collaboration, not ego. You share credit, own your mistakes, and approach problems as “we” rather than “they.”Someone who builds trust through direct, respectful communication: you raise concerns openly, give colleagues the benefit of the doubt, and resolve disagreements constructively rather than escalating them.A positive contributor to culture who understands that on a small team, every person has an outsized influence, and who wants to help build a workplace rooted in respect, accountability, and mutual support.EducationBS/BA in a life science or related discipline and a minimum of 8 years of related experience; orMS/MA in a related discipline and a minimum of 6 years of related experience; orPhD, PharmD, or RN in a related discipline and a minimum of 4 years of related experience; orAn equivalent combination of education and experience.