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Clinical Trial Operations Lead

3 weeks ago

Ottawa, Ontario, Canada Parexel International Full time

Parexel International is seeking a highly skilled Clinical Trial Operations Lead to join our team. As a key member of our global clinical trials operations, you will be responsible for ensuring the smooth execution of clinical trials from start to finish.

About the Role

The Clinical Trial Operations Lead will serve as the local study team leader on one or more studies, providing strategic planning and organizational skills to ensure the operational delivery of tasks. This role will oversee the preferred Contract Research Organization (CRO) and/or Country Trial Manager/Site Care Partner for assigned studies at country level in accordance with the overall project plan.

Key Responsibilities:

  • Serves as leader of the local study team on one or more studies.
  • Provides back up to or assumes the responsibilities of the GSM as needed.
  • Oversees the preferred CRO and/or Country Trial Manager/Site Care Partner for assigned studies at country level in accordance with the overall project plan.
  • Liaises with regulatory colleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethics Committees (ECs).

Requirements:

  • Bachelor's of Science or Bachelor's of Arts degree with a minimum 7 years of relevant operational clinical trial experience required.
  • Master's of Science or Master's of Business Administration degree with a minimum 6 years of relevant operational clinical trial experience required.