Senior Clinical Trial Manager

Senior Clinical Trials Manager | Medical Device / Health Tech

Boston, MA (hyrbid-onsite)| Full-time

A growing medical device / health tech company 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.

• 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

• 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

• 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