🛠 Tech Stack

💼 About This Role

You'll lead site monitoring activities and provide oversight to CRAs for clinical trials at a clinical-stage biotechnology company. You'll ensure studies are conducted according to protocol, ICH-GCP guidelines, and regulatory requirements. This role offers the chance to work on engineered organ development.

🎯 What You'll Do

• Provide operational leadership and guidance to internal and external CRAs.
• Author the Clinical Monitoring Plan and develop study-specific monitoring tools.
• Review monitoring outputs and conduct oversight monitoring activities.
• Track study startup activities, enrollment performance, and site metrics.

📋 Requirements

• Bachelor's degree in life sciences, nursing, or related field.
• 5+ years of clinical monitoring experience in pharma/biotech/CRO.
• Experience monitoring complex clinical trials (gene/cell therapy or transplant).
• Experience with CTMS and working knowledge of eTMF and EDC systems.

✨ Nice to Have

• Advanced degree preferred.
• Experience with academic centers or investigator sites new to industry trials.
• Experience supporting clinical systems development and UAT.

🎁 Benefits & Perks

• 💵 Base pay range $131,200-$196,800
• 🏥 Health benefits (implied by full-time role)
• 🧑‍💻 Hybrid work environment