🛠 Tech Stack

💼 About This Role

You'll lead end-to-end implementation and configuration of the eTMF platform, ensuring inspection readiness across all clinical studies. Your core impact is driving TMF strategy and governance while serving as the organization's subject matter expert. You'll collaborate with cross-functional teams to standardize processes and improve quality.

🎯 What You'll Do

• Lead eTMF platform implementation and configuration across studies
• Develop TMF SOPs, governance models, and operational workflows
• Manage TMF vendor performance and contractual compliance
• Establish TMF metrics and dashboards to monitor quality and risks

📋 Requirements

• 10+ years in biotech/pharma with direct TMF management experience
• eTMF system implementation experience
• Strong understanding of ICH-GCP and regulatory compliance

✨ Nice to Have

• Experience with clinical trial management and sponsor oversight
• Process improvement and continuous improvement initiatives

🎁 Benefits & Perks

• 💰 Competitive compensation with annual bonus and equity
• 🏥 Comprehensive benefits package
• 🌈 Equal opportunity employer with inclusive culture