Clinical Trial Manager (Consultant)

NeuroBionics Inc; United States; Remote; USD 65.000 - 95.000; Teilzeit

Zusammenfassung

NeuroBionics Inc. is seeking a part-time Clinical Trial Manager to oversee our first-in-human implantable neurostimulation study outside the United States.

The role involves hands-on operational execution, site activation, training, and ongoing oversight with approximately 10–15 hours per week during steady-state, rising during enrollment and travel weeks. You should bring CRC-to-CTM progression, strong medical device trial experience, and a firm grasp of GCP, regulatory requirements, and SIVs.

Qualifikationen

• Progressed from a clinical research coordinator (CRC) role into clinical trial management (CTM) or equivalent — hands-on experience running studies.
• Medical device implantable trial experience strongly preferred.
• 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.

Aufgaben

• Own AE/SAE monitoring, deviation management, and regulatory reporting.
• Lead Site Initiation Visits, site activation, and training programs; maintain essential documents and eTMF.
• Coordinate cross-functional activities with regulatory, engineering, and QA; communicate study status to stakeholders.

Kenntnisse

CRC to CTM path

Medical device trials

AE/SAE monitoring

SIVs & training

GCP knowledge

International trials

Jobbeschreibung

Clinical Trial Manager (Part-Time) — First-in-Human Study, OUS

About the Role

NeuroBionics is seeking an experienced clinical operations professional to help run our first-in-human (FIH) implantable neurostimulation study outside the United States (OUS) with expected enrollment early Q4 this year . This is a hands‑on, contractor role - roughly 10–15 hours/week during steady‑state periods, increasing to 25–35 hours/week during site travel and active enrollment weeks . Expect monthly travel to Europe beginning late October for patient enrollment and site oversight. This role is for someone who has come up through the clinical research coordinator ranks into a CTM‑level position, and who is comfortable operating without a large clinical operations department around them. This role is specifically suited to someone with medical device clinical trial experience. Device trials carry different operational demands (site training on procedures and devices, device accountability, physician learning curves, deviation patterns tied to technique rather than dosing), and we need someone who already speaks that language.

The Clinical Trial Manager is responsible for the operational execution and oversight of our OUS first-in-human study, from site activation through study conduct.

Duties and Responsibilities

• 1. Safety & Compliance Monitoring
  • 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 .
• 2. Site Readiness, Training, and Oversight
  • 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.
• 3. Cross‑Functional Coordination
  • 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.

Your Experience & Qualifications

NeuroBionics is a company driven by passionate individuals committed to advancing human health and creating life‑changing products. We seek talented and driven team members who prioritize patient care, and will thrive in a dynamic, independent, and results‑oriented environment. We're looking for an experienced clinical operations professional who has progressed from a clinical research coordinator (CRC) background into clinical trial management (CTM) or equivalent, with direct, hands‑on device trial experience — not just pharma.

Required Qualifications

• 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.

Study Conduct & Compliance

• 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 Experience

• 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).

Preferred Qualifications

• 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.