Clinical Affairs Specimen Operations Manager

175

Madison, WI, US
Base: $76,000.00 - $125,000.00; bonus/equity: bonu...
Fully remote
5+ years clinical regulatory experience
3+ years project management support
Supply and sample management setup
Exact Sciences is seeking a Clinical Affairs Specimen Operations Manager to oversee the logistical support of clinical studies, ensuring that supply and sample management meet study design requirements. This fully remote position requires strong project management skills and cross-functional collaboration to support clinical and regulatory initiatives

Job Summary

  • This role supports the logistical stand up of all clinical studies to ensure supply and sample management needs meet study design requirements.
  • The position involves leading defined small and medium-sized projects while coordinating activities for internal and external clinical studies.
  • Exact Sciences offers robust benefits including paid time off, health coverage, and a retirement savings plan to support employees in their purpose-driven careers.

Matching Summary

Match Score: 85

Exact Sciences is seeking a Clinical Affairs Specimen Operations Manager to oversee the logistical support of clinical studies, ensuring that supply and sample management meet study design requirements. This fully remote position requires strong project management skills and cross-functional collaboration to support clinical and regulatory initiatives.

Salary

Base: $76,000.00 - $125,000.00; Bonus/Equity: Bonus eligible; Benefits: PTO, health/dental/vision, retirement plan

Skills & Requirements

Must-have

  • 5+ years clinical regulatory experience
  • 3+ years project management support
  • Supply and sample management setup
  • Cross-functional team collaboration
  • Process improvement initiatives
  • Microsoft Office proficiency

Nice-to-have

  • Process and workflow design experience
  • CAPM certification preferred
  • FDA regulations and ICH GCP knowledge
  • Global regulatory understanding
  • Inclusion mindset and teamwork
  • Strong analytical problem-solving skills

Key Requirements

  • Bachelor's degree in health/life sciences or equivalent experience
  • Must be authorized to work in the US without sponsorship
  • Minimum 5 years experience in Clinical, IT, or Regulatory roles
  • Minimum 3 years experience in project management support

Work Rights

Must be currently authorized to work in the US

Tailored Resume

Cover Letter