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Clinical Trial Manager

2 months ago

Markham, Ontario, Canada Astellas Full time
Clinical Trial Manager Job Description

Astellas Pharma Inc. is a pharmaceutical company dedicated to developing innovative therapies for patients worldwide. 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 to ensure completion of project goals and objectives in compliance with GCP/ICH guidelines and regulatory requirements.
  • Lead cross-functional trial teams, including vendors, to ensure proper set-up of trial processes and plans.
  • Ensure accurate and up-to-date trial information within relevant tracking systems and provide regular updates to stakeholders.
  • Proactively identify and resolve issues that arise during trial conduct, managing escalations as needed.
  • Participate in the development of core trial documents, trial plans, and site communications, ensuring operational excellence.
  • Manage clinical trial budget, vendor contracts, and data in associated systems.
  • Ensure quality and completeness of the Trial Master File (TMF) for assigned clinical trials.
  • Participate in inspection readiness activities, coordinating clinical trial team deliverables.

Astellas is committed to conducting business with ethics and integrity, addressing unmet medical needs, and improving the health of people worldwide. If you are passionate about developing innovative therapies and working in a collaborative environment, we encourage you to apply for this exciting opportunity.