Contract – Trial Master File Manager
Cytokinetics
contract
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $65 - $80 per hour
Job Level
Mid-LevelSenior
About the role
- Lead day-to-day oversight and strategic management of study-specific TMFs
- Drive adherence to Cytokinetics’ TMF SOPs, policies, and regulatory requirements
- Support inspection preparation activities
- Provide regular TMF status and compliance reports to the Study Lead and key stakeholders
- Clarify functional document ownership and submission expectations
Requirements
- Bachelor’s Degree preferred
- 5+ years’ experience managing or supporting TMF activities for clinical research/biotech/CRO company
- 1+ years of experience serving as eTMF Administrator
- Working knowledge of CDSIC Trial Master File Reference Model and ALCOA+ standard
- Working knowledge of applicable FDA, Canadian, EU, and ICH guidelines
Benefits
- Health insurance
- 401(k) matching
- Flexible working hours
- Paid time off
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
TMF managementeTMF administrationCDSIC Trial Master File Reference ModelALCOA+ standardregulatory complianceclinical researchbiotechCRO operationsinspection preparationreporting
Soft skills
strategic managementcommunicationstakeholder engagementorganizational skillsleadership
Certifications
Bachelor's Degree