02 Sep
|
AbCellera
|
Montreal
02 Sep
AbCellera
Montreal
Join AbCellera as a Clinical Study Start-Up Manager and manage start-up projects for groundbreaking clinical trials. Ensure high-quality document handling and regulatory compliance in an accelerated environment. In this critical role, you'll lead the start-up activities through hands-on management of document collection and regulatory submissions.
Your expertise will help streamline the selection and qualification of study sites, ensuring adherence to global regulatory standards. Your efforts in resolving contract negotiations will further enhance study timelines. Key Responsibilities:
- Manage document collection and rigour for site activation
- Collaborate on submission packages with Regulatory team
- Maintain Trial Master File in inspection-ready condition
- Support site qualification and feasibility assessments
- Address queries from health authorities promptly
Requirements:
- Bachelor’s degree in Life Sciences or similar
- 8+ years of related clinical research experience
- Direct experience in start-up and site activation
- Familiarity with Canadian clinical trial regulations
- Robust organizational and communication skills, bilingual preferred
Your proactive involvement will be key to delivering innovative therapies to those in need.
📌 Lead Clinical Trial Start-Up Projects (Montreal)
🏢 AbCellera
📍 Montreal