Part-Time CTM, First-in-Human Neurostimulation (OUS)

NeuroBionics

Somerville (MA)

On-site

USD 80,000 - 110,000

Part time

4 days ago
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Job summary

NeuroBionics seeks an experienced Clinical Trial Manager for a first-in-human implantable neurostimulation study outside the United States. The role is a hands-on contractor position with ~10-15 hours/week during steady state, rising to 25-35 hours/week during site travel and enrollment, including monthly travel to Europe for enrollment and oversight.

This role suits someone who has progressed from a CRC background to CTM, with direct device trial experience and the ability to operate with

Qualifications

  • Progressed from CRC to CTM or equivalent with hands-on study management.
  • Medical device trial experience required; implantable device experience preferred.
  • Direct AE/SAE monitoring and regulatory reporting experience.
  • Experience conducting Site Initiation Visits (SIVs) and site training.

Responsibilities

  • Oversee operational execution from site activation to study conduct in OUS FIH.
  • Monitor safety, compliance, and regulatory reporting timelines.
  • Manage protocol deviations and CAPAs with sites and internal team.
  • Lead SIVs, training, and development of site materials and procedures.
  • Maintain essential documents and eTMF as system of record.

Skills

CRC to CTM
Medical device trials
AE/SAE monitoring
SIVs & training
Implantable device exp

Tools

eTMF

Job description

NeuroBionics seeks an experienced Clinical Trial Manager for a first-in-human implantable neurostimulation study outside the United States. The role is a hands-on contractor position with ~10-15 hours/week during steady state, rising to 25-35 hours/week during site travel and enrollment, including monthly travel to Europe for enrollment and oversight.

This role suits someone who has progressed from a CRC background to CTM, with direct device trial experience and the ability to operate with

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