Study Start-Up Specialist/Site Activation Partner - FSP

Parexel • Quebec, ON

10d

About The Position

The Site Activation Partner is responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and sponsor standards.

Requirements

• School diploma/certificate with equivalent combination of education, training and experience
• Minimum 2 years relevant experience in Clinical Trials environment and clinical site activation.
• Knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations
• Must be fluent in Local language and in English.

Nice To Haves

• BS/BA or bachelor’s degree in life sciences preferred
• Experience working in the pharmaceutical industry/or CRO is an asset
• Multi-language capability is an asset

Responsibilities

• Initiate and coordinate activities and essential documents management towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for sites initiation
• Provide support to resolve issues or concerns and timely escalation of Site issues where applicable
• Manage and coordinate with other supporting roles to ensure timely site activation and operational activities
• Collaborate with in country regulatory group, and provide related/applicable site documents, as well as in countries where parallel submissions (Regulatory authority and ethics) are required
• Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines
• Identify and resolve investigator site issues

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED