TMF Specialist
@ Nuvation Bio

Hybrid
$120,000
Hybrid
Full Time
Posted 1 day ago

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XXXXXXXX XXXXXXXXXXXXX XXXXXXXXXX***** @nuvationbio.com
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Job Details

Who We Are

Nuvation Bio is a biopharmaceutical company addressing significant unmet needs in oncology by developing differentiated therapeutic candidates that improve quality of life and survival for cancer patients.

What You’ll Be Doing

The TMF Specialist works proactively with Clinical Operations, Clinical Quality, and other teams to ensure the Trial Master File (TMF) is current and inspection ready. This role includes managing regulatory documents in accordance with GCP, ICH Guidelines, and applicable regulations.

  • Serve as the primary contact for eTMF, CTMS, and other clinical systems.
  • Manage the document lifecycle including uploading, versioning, reviewing, approving, and archiving.
  • Conduct routine TMF quality reviews and perform quality control checks.
  • Assist in SOP development and support internal/external audits.
  • Provide technical support and system troubleshooting.

What You Will Be Responsible For

Collaborating with global clinical teams to maintain inspection readiness and ensuring compliance with GCP, ICH E6 (R3), FDA, EMA, and other regulations. This role may also serve as the System Owner for clinical systems used at Nuvation Bio.

Minimum Requirements & Core Competencies

  • Bachelor’s degree in life sciences, healthcare, or a related field (or equivalent experience).
  • 2+ years working with electronic TMFs, clinical trial operations, and ICH/GCP guidelines.
  • Excellent organizational, communication, and problem solving skills.
  • Proficiency with eTMF systems like Veeva Vault, Phlexglobal, and Wingspan.
  • Ability to work independently and as part of a team in a fast-paced setting.

Perks & Benefits

Competitive salary, bonus, and equity plans, unlimited vacation, comprehensive medical benefits, and 401K with company matching.

Key skills/competency

  • eTMF
  • CTMS
  • GCP
  • Regulatory Compliance
  • Quality Control
  • Clinical Operations
  • SOP Development
  • System Maintenance
  • Documentation
  • Audit Support
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How to Get Hired at Nuvation Bio

🎯 Tips for Getting Hired

  • Customize Your Resume: Tailor your resume to highlight clinical operations experience.
  • Show Regulatory Know-How: Emphasize familiarity with GCP and ICH guidelines.
  • Highlight eTMF Skills: Include experience with Veeva Vault and similar platforms.
  • Prepare for Technical Questions: Get ready to discuss system management and quality control.

📝 Interview Preparation Advice

Technical Preparation

Review eTMF systems best practices.
Study regulatory compliance guidelines.
Practice system troubleshooting scenarios.
Familiarize with CTMS operations.

Behavioral Questions

Describe a challenging system issue handled.
Explain a time you ensured compliance.
Discuss teamwork during fast-paced projects.
Share problem-solving under regulatory pressure.

Frequently Asked Questions