Sr. Clinical Affairs Specimen Operations Manager

Exact Sciences

Madison, WI, US
Base: $91,000.00 - $155,000.00; bonus/equity: bonu...
Hybrid
7+ years clinical trial operations experience
Specimen logistics and sample management expertise
Cross-functional project management skills
Exact Sciences is seeking a Sr. Clinical Affairs Specimen Operations Manager to lead specimen logistics for clinical studies. The role requires extensive experience in clinical trial operations and offers competitive benefits within a purpose-driven, inclusive company culture focused on cancer prevention and treatment

Job Summary

  • This role leads the planning and execution of specimen logistics for clinical studies to ensure reliable support for study designs and evidence generation.
  • The position requires translating complex study requirements into actionable plans while managing key performance metrics like kit usage and turnaround times.
  • Exact Sciences offers a robust benefits package including paid time off, parental leave, retirement savings, and comprehensive health coverage.

Matching Summary

Match Score: 85

Exact Sciences is seeking a Sr. Clinical Affairs Specimen Operations Manager to lead specimen logistics for clinical studies. The role requires extensive experience in clinical trial operations and offers competitive benefits within a purpose-driven, inclusive company culture focused on cancer prevention and treatment.

Salary

Base: $91,000.00 - $155,000.00; Bonus/Equity: Bonus eligible; Benefits: PTO, parental leave, retirement plan, medical/dental/vision

Skills & Requirements

Must-have

  • 7+ years clinical trial operations experience
  • Specimen logistics and sample management expertise
  • Cross-functional project management skills
  • FDA regulations and ICH GCP knowledge
  • Process improvement and workflow design

Nice-to-have

  • CAPM certification preferred
  • Global regulatory understanding
  • Inclusion mindset and teamwork
  • Experience with clinical systems functionality
  • Mobile device and computer proficiency

Key Requirements

  • Bachelor's degree in health or life sciences
  • 7+ years in clinical trial operations or specimen management
  • 3+ years in project management support role
  • Knowledge of FDA regulations and ICH GCP

Work Rights

Not specified

Tailored Resume

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