Senior Clinical Trial Manager

We’re hiring a Senior Clinical Trials Manager to own the full lifecycle execution of clinical studies, including regulatory trials. This is a hands-on, highly operational role for someone who knows how to stand up studies from the ground up and drive them to completion.You’ll lead clinical execution from protocol development through final study report and act as the primary link between internal teams and external sites, investigators, IRBs, CROs, and vendors. This role plays a key part in generating high-quality clinical evidence that supports regulatory submissions.What You’ll DoOwn clinical study execution from feasibility through close-outLead site selection, activation, enrollment, monitoring, and overall study managementAuthor and manage protocols, IRB/Ethics submissions, informed consent forms, and essential documentsServe as the primary point of contact for clinical sites and investigatorsOversee clinical data operations, including CRFs/eCRFs, data review, query resolution, and database lockManage study timelines, budgets, vendors, and CRO performanceCommunicate directly with sites (and subjects when needed) to resolve issues quicklyEnsure compliance with FDA regulations, ICH-GCP, ISO 14155, and applicable medical device or SaMD guidancePartner cross-functionally with regulatory, product, engineering, data, and legal teamsBuild and scale clinical operations processes, SOPs, and infrastructureWhat You Bring5+ years of hands-on clinical operations experience running trials for FDA-regulated medical devices, digital health, or SaMDProven experience managing external clinical sites and CROsStrong background authoring clinical protocols, IRB submissions, and ICFsSolid understanding of clinical data management and study reportingDeep familiarity with FDA device pathways such as IDE, De Novo, and 510(k)Experience owning budgets, timelines, and vendor relationshipsClear, confident communicator who is comfortable presenting to leadershipBachelor’s degree required; advanced degree preferredACRP or SOCRA certification is a plusNice to HaveExperience with connected devices, biosensors, or consumer health technologyExposure to real-world evidence or decentralized and hybrid trialsBackground in a startup or high-growth environmentExperience supporting FDA pre-submissions or breakthrough programs