Global SSU Lead - Remote Site Start-Up Expert

Parexel International; Canada; Remote; CAD 90,000 - 130,000; Full time

Job summary

Parexel FSP in Canada seeks a Global Site Start-up Lead responsible for global execution of site activation for assigned trials, ensuring efficiency, timeliness, and compliance with SOPs and ICH/GCP. This role partners with CROs and internal teams to drive cross-functional collaboration.

You will lead site start-up strategy, country start-up planning, regulatory submissions support, TMF documentation, and risk mitigation, with up to 25% travel. 4–6 years of experience required.

Qualifications

• 4-6 years of experience in SSU or site start-up.
• Knowledge of ICH/GCP and regulatory guidelines.
• Experience managing CRO/vendor relationships.
• Ability to lead cross-functional teams.
• Strong data-driven decision making.

Responsibilities

• Develop the site start up strategy for each study and monitor risks.
• Coordinate country start-up activities and regulatory submissions.
• Lead end-to-end site start-up management including TMF filing and document collection.
• Represent SSU on cross-functional teams and escalate challenges as needed.
• Recommend and participate in process improvements across SSU processes.

Skills

Leadership

Interpersonal skills

Data-driven planning

Effective communication

Vendor management

Project management

Regulatory knowledge

Tools

CTMS

TMF

PowerPoint

Word

Excel

Job description

Parexel FSP in Canada seeks a Global Site Start-up Lead responsible for global execution of site activation for assigned trials, ensuring efficiency, timeliness, and compliance with SOPs and ICH/GCP. This role partners with CROs and internal teams to drive cross-functional collaboration.

You will lead site start-up strategy, country start-up planning, regulatory submissions support, TMF documentation, and risk mitigation, with up to 25% travel. 4–6 years of experience required.