Note: The job is a remote job and is open to candidates in USA. NeuroBionics is advancing human health through life-changing products. The company seeks a Clinical Trial Manager to oversee the operational execution of an outside-the-United-States first-in-human implantable neurostimulation study, including safety monitoring, site activation, training, essential document management, data completeness, and cross-functional coordination.
Responsibilities
- Own AE/SAE monitoring and reporting — track adverse events and serious adverse events against protocol-defined timelines, ensure proper documentation, escalation, and regulatory reporting (including sponsor and IRB/ethics committee notifications as required)
- Manage study deviations — identify, document, assess, and follow up on protocol deviations; work with sites and the broader team to implement corrective and preventive actions
- Oversee proper conduct of the study — day-to-day operational oversight ensuring the trial runs per protocol, GCP, and applicable OUS regulatory requirements**, including oversight of the informed consent process in coordination with the local site monitor**
- Conduct Site Initiation Visits (SIVs) — prepare and lead SIVs to get sites activated and ready to enroll, including device/procedure training as part of site startup
- Develop and deliver training programs — build training materials and run sessions for site staff, investigators, and internal team members on protocol requirements, device use, and study procedures
- Own essential documents — develop CRFs and collect, track, and maintain completeness of essential documents (e.g., signed consents, IRB/EC approvals, monitoring visit reports) throughout the study; set up and maintain the eTMF as the system of record for these documents
- Own data completeness — track CRF completeness and drive query resolution with site staff; the local monitor verifies data accuracy during site visits, but the CTM owns overall timeliness and follow-through
- Work closely with regulatory, engineering, and quality functions as issues arise — this is a small, cross-functional team, not a siloed clinical department
- Communicate study status, risks, and safety findings clearly to internal stakeholders and leadership
Skills
- Progressed from a clinical research coordinator (CRC) role into clinical trial management (CTM) or equivalent — hands-on experience running studies, not only managing from a distance
- Medical device trial experience required; implantable device experience strongly preferred given the nature of this study
- Direct experience with AE/SAE monitoring, reporting, and protocol deviation management
- Experience conducting Site Initiation Visits (SIVs) and site training
- Strong working knowledge of GCP and applicable device regulatory frameworks (ISO 14155 familiarity a plus)
- Comfortable working part-time/fractionally within a small, resource-constrained team — able to operate independently with minimal clinical ops infrastructure around you
- International/OUS clinical trial experience — familiarity with running trials outside the US, including working with non-US ethics committees/IRBs and site relationships (Europe and/or Canada experience valuable given current site locations)
- Medical device trial experience required; implantable device experience strongly preferred given the nature of this study
- Strong working knowledge of GCP and applicable device regulatory frameworks (ISO 14155 familiarity a plus)
- International/OUS clinical trial experience — familiarity with running trials outside the US, including working with non-US ethics committees/IRBs and site relationships (Europe and/or Canada experience valuable given current site locations)
- Experience specifically with neurostimulation, implantable, or other active implantable medical devices
- Prior first-in-human (FIH) study experience
- Existing relationships with OUS sites, IRBs, or ethics committees relevant to this program
Benefits
- Contractor role
- Part-time/fractional work arrangement, roughly 10–15 hours/week during steady-state periods and 25–35 hours/week during site travel and active enrollment weeks
- Monthly travel to Europe beginning late October for patient enrollment and site oversight
Company Overview