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 activationEnsure submission packages meet regulatory standardsAdapt Informed Consent Forms to local regulationsTrack regulatory approval statuses globallyFacilitate negotiations of Clinical Trial Agreements and budgetsRequirements:Bachelor's degree in Life Sciences or related field8+ years in clinical research, preferably in biotech or CROHands-on experience in study start-up activitiesStrong knowledge of ICH-GCP and Health Canada regulationsExceptional communication skills, French preferredYour 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