Senior Clinical Trial Manager

Senior Clinical Trials Manager | Medical Device / Health Tech Boston, MA (hyrbid-onsite)| Full-time A growing medical device / health techcompany is looking for a Senior Clinical Trials Manager to own clinical study execution end to end. This is a hands‑on role for someone who's run trials before, not just reviewed them — you'll stand up studies from scratch, manage clinical sites, write IRB and informed consent docs, and drive studies to the finish line on time and on budget. What you’ll do Own clinical study execution from protocol development through final study report, including feasibility, site selection, activation, enrollment, monitoring, and close‑out Write and manage IRB/Ethics submissions, informed consent forms, and study essential documents Select, qualify, and manage third‑party clinical sites and investigators, serving as the main point of contact for site teams Oversee clinical data operations, including eCRF design, data review, and query resolution Communicate directly with sites and subjects, solving problems in real time Build and manage study timelines, budgets, and risk mitigation plans, with clear reporting to leadership Ensure compliance with FDA regulations (21 CFR Parts 11, 50, 56, 812, 820), ICH‑GCP, ISO 14155, and SaMD guidance Manage CRO and vendor relationships, including contract negotiation and performance oversight Partner cross‑functionally with regulatory, product, engineering, and data science teams Build and scale the clinical operations function, including SOPs, templates, and tracking systems What you bring 5+ years of hands‑on clinical operations experience running studies for FDA‑regulated medical devices, SaMD/digital health, or combination products Demonstrated experience managing third‑party clinical sites through the full lifecycle Proven ability to author IRB/Ethics submissions, ICFs, and clinical protocols 3+ years of cross‑functional program management spanning clinical, engineering, and regulatory Strong clinical data management knowledge, including eCRF design and database lock processes Fluency in FDA device regulations (IDE, De Novo, 510(k)), ICH‑GCP, ISO 14155, and SaMD frameworks Experience with study budgeting, vendor management, and CRO oversight Strong written and verbal communication, comfortable across protocol writing, site visits, and executive updates Bachelor's required; advanced degree (MS, MPH, PhD, or clinical doctorate) preferred ACRP or SOCRA certification a plus Bonus points Experience with biosensing devices, consumer health tech, or wellness platforms pursuing clinical validation Familiarity with RWE study designs and decentralized/hybrid trial models Background in a high‑growth startup, building processes from the ground up Experience supporting breakthrough device designations or pre‑submission meetings #J-18808-Ljbffr BioTalent Ltd