Clinical Trial Management Specialist

5 days ago

Canada ICON Strategic Solutions Full time
Job Summary

We are seeking a highly skilled Clinical Trial Management Specialist to join our team at ICON Strategic Solutions.

The ideal candidate will have experience in local trial management, with a strong understanding of ICH-GCP and company standard operating procedures. They will be responsible for ensuring top-quality end-to-end trial delivery at a country level, managing the consistency of Local Trial Management duties and processes.

The successful candidate will serve as the country-level single point of contact on the study for internal partners, overseeing the execution of local milestones from feasibility through study close out. They will also manage and oversee central IRB and other local vendors, including set up of vendor purchase orders, invoice review and approval, and change-orders.

Key Responsibilities:

  • Manage and oversee local trial management activities, ensuring compliance with ICH-GCP and company SOPs.
  • Coordinate with internal partners, including Clinical Trial Managers, Clinical Operations, and Global Trial Leader, to ensure seamless trial execution.
  • Develop and implement strategies to improve trial efficiency and quality.
  • Collaborate with assigned Local Trial Manager(s), Lead Site Manager, Site Managers, Clinical Trial Associates, and Site Contract Managers to outline accountabilities/responsibilities and provide support and training.
Requirements

To be successful in this role, you will need:

  • Bachelor's degree in a health or science-related field.
  • 2 years of local trial management experience or mutually agreed clinical trial experience.
  • Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols, and associated protocol-specific procedures.
  • Cross-therapeutic area trial management experience required.
  • Specific therapeutic area experience may be required depending on the position.
  • Strong IT skills in appropriate software and company systems.
  • Proficient in speaking and writing English and country language.

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