Site Activation Partner - FSP

The Site Activation Partner at Parexel is responsible for leading or supporting operational activities from start-up to close-out for clinical studies, ensuring compliance with laws, GCP, and sponsor standards. The role involves site activation, issue resolution, and collaboration with regulatory teams.

Location: Canada

Responsibilities

• Initiate and coordinate activities and essential documents management for Investigator Initiation Package (IIP) approval and site initiation.
• Support resolution of site issues and escalate as needed.
• Manage and coordinate with supporting roles to ensure timely site activation and operational activities.
• Collaborate with in-country regulatory groups and provide site documents for regulatory and ethics submissions.
• Update and maintain clinical trial systems tracking site compliance and performance.
• Identify and resolve investigator site issues.

Requirements

• School diploma/certificate with equivalent education, training, and experience; BS/BA or bachelor’s degree in life sciences preferred.
• Minimum 2 years relevant experience in Clinical Trials environment and clinical site activation.
• Experience working in the pharmaceutical industry or CRO is an asset.
• Knowledge of clinical trial methodologies, ICH/GCP, FDA, and global and local country regulations.
• Fluent in local language and English; multi-language capability is an asset.

Additional Information

• Originally posted on Himalayas