Job Summary

• Partner with the clinical affairs team to drive clinical quality assurance (CQA) activities to include internal, vendor, and site audits, standard operating procedure (SOP) development and review, and process improvement.
• The Senior Clinical Quality Specialist will serve as a quality subject matter expert (SME) to clinical affairs project teams for adherence to quality and compliance standards, and will provide support to members of multidisciplinary project teams, both internally and externally.
• Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage.

Matching Summary

Salary

Base: $91,000.00 - $155,000.00; Bonus/Equity: bonus eligible; Benefits: paid time off, paid leave, retirement savings, wellness, health benefits

Skills & Requirements

Key Requirements

• Bachelor's degree in Life Sciences
• 6+ years clinical/quality experience
• 5+ years ICH GCP E6 R(2) implementation
• 3+ years clinical operations/QA
• 3+ years CTMS, EDC, eTMF, sample systems
• 4+ years end-to-end trial activities
• 4+ years protocol/report writing
• Authorization to work in US without sponsorship

Work Rights