Drive clinical trial success as a Clinical Study Start-Up Manager with AbCellera. Lead essential start-up activities and ensure compliance throughout the clinical research process.

Joining

AbCellera's Clinical Operations team, you will oversee start-up activities for clinical trials, managing document collection and regulatory submissions. Your deep knowledge of GCP, ethics, and site activation will be pivotal in accelerating study timelines. This role requires a meticulous approach to ensure the highest quality in all essential documentation and adherence to regulations. Key Responsibilities:

- Oversee essential documentation for study activation
- Ensure submission packages meet regulatory standards
- Adapt Informed Consent Forms to local regulations




- Track regulatory approval statuses globally
- Facilitate negotiations of Clinical Trial Agreements and budgets

Requirements:

- Bachelor’s degree in Life Sciences or related field
- 8+ years in clinical research, preferably in biotech or CRO
- Hands-on experience in study start-up activities
- Robust knowledge of ICH-GCP and Health Canada regulations
- Exceptional communication skills, French preferred

Your role will accelerate the path to breakthrough medicines by ensuring effective and compliant site activations.

📌 Clinical Study Start-Up Manager at AbCellera (Montreal)
🏢 AbCellera
📍 Montreal