Clinical Trial Manager

4 days ago

Markham, Ontario, Canada Astellas Full time
About the Role

Astellas Pharma Inc. is a global pharmaceutical company committed to developing innovative therapies for patients. We are seeking a skilled Clinical Trial Manager to support the planning, set-up, and execution of assigned drug trials.

Key Responsibilities
  • Manage day-to-day trial operations, ensuring completion of project goals and objectives in compliance with GCP/ICH guidelines and regulatory requirements.
  • Lead or support cross-functional trial teams, including vendors, to ensure operational excellence and quality of trial deliverables.
  • Proactively identify and resolve issues that arise during trial conduct, managing escalations and ensuring timely data cleaning and analysis.
  • Participate in or lead the development of core trial documents, trial plans, and site communications, ensuring operational excellence and quality across investigative sites, vendors, and data.
  • Manage clinical trial budget, vendor contracts, and associated systems, ensuring timely and accurate tracking and data.
  • Participate in inspection readiness activities, coordinating clinical trial team deliverables and ensuring quality and completeness of the Trial Master File (TMF).
Requirements

This position requires a strong understanding of clinical trial operations, regulatory requirements, and vendor management. The ideal candidate will have excellent communication and project management skills, with the ability to work collaboratively with cross-functional teams and vendors.

Astellas is committed to providing a supportive and inclusive work environment. If you are a motivated and detail-oriented individual with a passion for clinical trial management, we encourage you to apply for this exciting opportunity.

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