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Global Study Operations Lead

3 weeks ago

London, Ontario, Canada Parexel International Full time

About the Role

Parexel International is seeking a Global Study Operations Lead to join our team. As a key member of our operations team, you will be responsible for leading the operational delivery of clinical trials from study startup through conduct and closeout.

Main Responsibilities:

  • Lead local study teams on multiple studies, providing guidance and support as needed.
  • Develop and maintain accurate country-level plans, including timelines, budgets, risks, and quality plans.
  • Liaise with regulatory colleagues and stakeholders to agree on submission strategies to Health Authorities (HAs) and Ethics Committees (ECs).
  • Collaborate with accountable roles to identify and manage deviations and risks in study startup and execution.
  • Provide input on recruitment milestones during planning and develop study-level plans.
  • Communicate with internal stakeholders, CROs, and vendors to ensure efficient and timely study delivery.
  • Assure follow-up and coordination of regional and site quality events, protocol deviations, data issues, metrics review, site issues, and risks.

Key Skills and Qualifications:

  • Proven experience in clinical trial operations with a strong understanding of regulatory requirements.
  • Excellent leadership and communication skills, with the ability to build strong relationships with cross-functional teams.
  • Strong problem-solving skills, with the ability to analyze complex data and make informed decisions.
  • A scientific or technical degree is preferred.