🛠 Tech Stack

💼 About This Role

You'll manage Trial Master File (TMF) and Clinical Trial Management System (CTMS) operations for a late-stage oncology company. You'll ensure inspection-readiness of clinical trial documents. This role offers leadership of TMF specialists and collaboration with cross-functional teams.

🎯 What You'll Do

• Oversee TMF document upload, review, and approval
• Manage eTMF and CTMS integration and maintenance
• Report TMF metrics and reconcile queries/CAPAs
• Supervise TMF specialists and external vendors

📋 Requirements

• 8+ years in pharmaceutical or regulated environment
• 6+ years in Records Management including 4+ with eTMF systems
• Strong knowledge of FDA Regulations, ICH Guidelines, and GCP
• Experience with DIA (CDISC) TMF Reference Model

✨ Nice to Have

• RN or bachelor's/master's degree
• Experience selecting CROs/vendors
• Knowledge of clinical development lifecycle

🎁 Benefits & Perks

• 🏥 Medical, dental, vision insurance
• 💰 401(k) with company match
• 🏖️ Paid time off and holidays
• 📚 Professional development opportunities

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter Phone Screen· 30 min
2. 2Hiring Manager Interview· 45 min
3. 3Panel Interview· 60 min