Remote Regional Site Start-Up Lead

Parexel; United States; Remote; USD 49,000 - 78,000; Full time

Job summary

Parexel is seeking a Regional Site Start Up II to drive site activation across trials, focusing on Canada. You will lead timelines, coordinate with sites, and ensure regulatory compliance with ICH-GCP standards.

The role requires strong interpersonal and leadership skills, a data-driven approach, and 3–4 years of experience in site start-up, with familiarity across US and Canada regulatory requirements.

Qualifications

• Bachelor’s degree required.
• 3–4 years of experience in site start-up.
• Experience with US and Canada regulatory requirements.
• Knowledge of ICH-GCP.
• Vendor management and cross-functional collaboration experience.

Responsibilities

• Lead and deliver site activation timelines for assigned sites.
• Gather and organize essential documents for regulatory submission.
• Maintain CTMS data and ensure TMF readiness.
• Review Informed Consent Forms and assist with translations as needed.
• Ensure adherence to regulatory requirements across regions.
• Collaborate with internal and external stakeholders to optimize processes.

Skills

Interpersonal skills

Leadership

Data-driven planning

Communication skills

Time management

Prioritization

Vendor management

Team collaboration

Problem solving

Education

Bachelor’s Degree

Tools

CTMS

TMF

MS Office

PowerPoint

Excel

Job description

Parexel is seeking a Regional Site Start Up II to drive site activation across trials, focusing on Canada. You will lead timelines, coordinate with sites, and ensure regulatory compliance with ICH-GCP standards.

The role requires strong interpersonal and leadership skills, a data-driven approach, and 3–4 years of experience in site start-up, with familiarity across US and Canada regulatory requirements.