Clinical Trial Manager, Consultant

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Oversee the operational implementation and management of the OUS first-in-human implantable neurostimulation study from site activation through the study's execution.

• Monitor and document adverse events and serious adverse events according to protocol-defined timelines.

• Ensure appropriate documentation, escalation, and regulatory reporting, including necessary notifications to sponsors and IRB/ethics committees.

• Identify, record, evaluate, and follow up on any protocol deviations.

• Implement corrective and preventive measures in collaboration with sites and the wider team.

• Provide daily operational oversight to guarantee adherence to protocol, GCP, and relevant OUS regulatory standards.

• Supervise the informed consent process in conjunction with the local site monitor.

• Prepare and conduct Site Initiation Visits to activate sites and ready them for participant enrollment.

• Deliver device and procedure training during the site startup phase.

• Create training materials and facilitate sessions for site personnel, investigators, and internal team members.

• Develop Case Report Forms (CRFs) and gather, monitor, and maintain essential documents.

• Establish and manage the electronic Trial Master File (eTMF) as the official record-keeping system.

• Track the completeness of CRFs and resolve queries with site staff.

• Collaborate with regulatory, engineering, and quality departments.

• Communicate study progress, risks, and safety findings to internal stakeholders and leadership.

⛳️ Requirements

• Progressed from a clinical research coordinator (CRC) position into clinical trial management (CTM) or a similar role.

• Hands-on experience in conducting clinical studies, rather than just overseeing from a distance.

• Medical device trial experience is required.

• Experience with implantable devices is strongly preferred.

• Direct involvement with AE/SAE monitoring, reporting, and management of protocol deviations.

• Experience in conducting Site Initiation Visits (SIVs) and training for site personnel.

• Comprehensive knowledge of GCP and relevant device regulatory frameworks.

• Familiarity with ISO 14155 is an advantage.

• Comfortable working part-time/fractionally within a small, resource-limited team.

• Ability to operate independently with minimal clinical operations infrastructure.

• Experience with international/OUS clinical trials.

• Knowledge of non-US ethics committees/IRBs and site relationships.

• Experience in Europe and/or Canada is considered valuable.

• Preference for candidates with experience in neurostimulation, implantable, or other active implantable medical devices.

• Prior experience with first-in-human (FIH) studies is preferred.

• Existing connections with OUS sites, IRBs, or ethics committees relevant to the program are preferred.

🏝️ Benefits

• Part-time consulting/contract position.

• Approximately 10–15 hours per week during steady periods, increasing to 25–35 hours per week during site travel and active enrollment phases.

• Monthly travel to Europe starting in late October for patient enrollment and site oversight.