Business Operations Manager

3 weeks ago


Markham, Ontario, Canada Astellas Full time
About the Role

Astellas Pharma Inc. is seeking a highly skilled Business Operations Manager to join our Clinical Operations Excellence team. As a key member of our team, you will play a critical role in the successful execution of our Study Start Up (SSU) activities.

Key Responsibilities
  • Manage and lead the day-to-day operations within SSU to ensure completion of established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
  • Develop and implement standards for designated functional areas, ensuring consistency and compliance across the organization.
  • Provide oversight and direction to team members for functional and study-related deliverables, ensuring timely completion and high-quality results.
  • Collaborate with cross-functional teams, including IT and IS, to define standard operational terminology and data conventions used for clinical systems.
  • Manage and may lead functional and cross-functional internal teams, providing guidance and support to team members as needed.
Requirements
  • Proven experience in Study Start Up and clinical operations, with a strong understanding of GCP/ICH guidelines and regulatory requirements.
  • Excellent communication and leadership skills, with the ability to effectively manage and motivate team members.
  • Strong analytical and problem-solving skills, with the ability to identify and escalate issues that arise related to support functional deliverables.
  • Ability to work in a fast-paced environment, with multiple priorities and deadlines.


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