Regional Site Start-Up Lead II – Canada

Parexel; Oregon; Hybrid; USD 90,000 - 120,000; Full time

Job summary

Parexel is seeking a Regional Site Start Up II to lead site activation across clinical trials in the US and Canada. You will coordinate cross-functional teams, gather regulatory documents, and ensure timely activation while maintaining regulatory compliance and strong site relationships.

Ideal candidates bring 3–4 years of US/Canada experience, proficiency with CTMS/TMF, and a data-driven, proactive mindset to optimize start-up processes and timelines.

Qualifications

• Bachelor's degree required (minimum)
• 3–4 years of experience in US/Canada
• Experience with site start-up and activation in clinical trials
• Knowledge of ICH-GCP and regulatory guidelines
• Proven ability to manage multiple sites and timelines
• Strong communication and leadership abilities

Responsibilities

• Lead and deliver site activation timelines for assigned sites
• Gather, organize and share essential documents for regulatory submissions
• Maintain site information in CTMS and ensure TMF readiness
• Ensure regulatory packages meet country requirements and ICH-GCP compliance
• Review Informed Consent Forms as requested
• Translate essential documents for regulatory submissions as needed
• Provide regional expertise to address geographic challenges and act as primary contact for sites
• Update trackers with study information, risks, and mitigations
• Support inspection readiness related to site start-up documents
• Collaborate with internal and external stakeholders to ensure alignment and timely execution

Skills

Interpersonal leadership

Data-driven planning

Communication

Time management

Vendor management

CTMS proficiency

TMF knowledge

Regulatory knowledge

Team collaboration

Problem solving

Education

Bachelor's Degree

Tools

CTMS

TMF

MS Office

PowerPoint

Word

Excel

Job description

Parexel is seeking a Regional Site Start Up II to lead site activation across clinical trials in the US and Canada. You will coordinate cross-functional teams, gather regulatory documents, and ensure timely activation while maintaining regulatory compliance and strong site relationships.

Ideal candidates bring 3–4 years of US/Canada experience, proficiency with CTMS/TMF, and a data-driven, proactive mindset to optimize start-up processes and timelines.