Hybrid Senior Clinical Trial Manager

Posted 5 days ago

Apply now

About the role

  • Develop and manage operational plans, charters, and manuals to support trial execution in compliance with regulatory and internal standards
  • Review of protocol and protocol amendments​
  • Coordinate the development of and manage updates of the Trial Oversight Plan​
  • Review of the Investigator's Brochure from DevOps perspective​
  • Review of the Clinical Trial Application submission package​​
  • Review of Regulatory Green Light packages
  • Develop the Global Master ICF
  • Act as a key liaison between internal stakeholders and CROs to oversee sponsor oversight visits and ensure quality and compliance
  • Collaborate with the CRO and/or internal functions to oversee site selection based on feasibility assessments
  • Monitor and manage vendor deliverables across trial operations
  • Ensure ongoing accuracy and completeness of the eTMF, supporting inspection readiness and regulatory compliance
  • Drive the Operational Data Base review for the trial
  • Participate in inspection readiness activities, support QA in audit preparations, and conduct site visits as needed

Requirements

  • Bachelor's or Master's degree with relevant specialization; Master's degree preferred
  • Minimum requirement: 8+ years in clinical operations
  • Significant experience leading and managing clinical trials
  • Experience in leading multiple complex trials, maintenance of trial documentation, CRO engagement, and budget monitoring
  • Some experience managing/guiding internal (cross-functional) and external (CRO) teams

Benefits

  • Health insurance
  • 401(k) matching
  • Flexible work hours
  • Paid time off
  • Remote work options

Job title

Senior Clinical Trial Manager

Job type

Experience level

Senior

Salary

$122,000 - $183,000 per year

Degree requirement

Bachelor's Degree

Location requirements

Report this job

See something inaccurate? Let us know and we'll update the listing.

Report job