Drive regulatory document readiness and clinical trial activation for Parexel FSP across Canada, applying ICH-GCP knowledge and strong stakeholder communication. The role is remote.

This Regional Site Start Up II position leads site start-up activities, supports regulatory submissions, and maintains inspection-ready documentation. You will partner with clinical sites, sponsors, and cross-functional stakeholders to meet study milestones. Attention to detail, data-driven planning, and effective communication are central to the work.

Key Responsibilities:

- Compile documents for regulatory and sponsor requirements
- Review site packages against country requirements and TMF standards
- Facilitate essential document translations when required




- File start-up documents in inspection-ready trial master files
- Support inspection readiness for site activation documentation

Requirements:

- Three to four years of clinical experience
- Bachelor's Degree minimum
- Knowledge of ICH-GCP and regulatory requirements
- Technical proficiency with CTMS, TMF, and Microsoft applications
- Robust written, verbal, and presentation communication skills

Bring regulatory coordination, document control, and clinical trial start-up expertise to Parexel FSP's Canadian activation work.

📌 Clinical Trial Regulatory Start-Up Lead (Montreal)
🏢 Parexel
📍 Montreal