Clinical Operations Manager

Nanopathinc

Cambridge, MA, United States
On-site
Clinical study start-up and execution
Irb submissions and regulatory coordination
Site selection, qualification, initiation, and monitoring
Nanopath is developing a first-in-class in vitro diagnostics platform to transform how diseases are diagnosed, aiming to replace lengthy molecular testing workflows by bringing rapid, high-quality diagnostics closer to the patient

Job Summary

  • Nanopath is developing a first-in-class in vitro diagnostics platform to transform how diseases are diagnosed, aiming to replace lengthy molecular testing workflows by bringing rapid, high-quality diagnostics closer to the patient.
  • The Clinical Operations Manager will play a critical role in the planning, execution, and oversight of Nanopath’s clinical studies, supporting study start-up, site initiation, monitoring, and ongoing study management.
  • Nanopath is committed to building a diverse and inclusive workplace and encourages individuals to apply even if they don't meet every single qualification.

Matching Summary

Nanopath is developing a first-in-class in vitro diagnostics platform to transform how diseases are diagnosed, aiming to replace lengthy molecular testing workflows by bringing rapid, high-quality diagnostics closer to the patient.

Skills & Requirements

Must-have

  • clinical study start-up and execution
  • IRB submissions and regulatory coordination
  • site selection, qualification, initiation, and monitoring
  • GCP compliance and core clinical documentation
  • vendor and reference laboratory coordination
  • GCP, ICH guidelines, and clinical trial regulations

Nice-to-have

  • building clinical trial infrastructure at early-stage companies
  • health equity and underserved populations
  • corporate sustainability

Key Requirements

  • 5+ years of experience in clinical operations
  • Bachelor's degree in life sciences or related field
  • Demonstrated experience with study start-up
  • Hands-on experience with site monitoring
  • Experience working with central labs, CROs, and research sites
  • Prior involvement in diagnostic/medical device clinical trials

Work Rights

Not specified

Tailored Resume

Cover Letter