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Senior Manager, Clinical and Quality (IT) Applications

Job description

Senior Manager, Clinical and Quality (IT) Applications – High Growth Oncology Biotech – Seattle, WA

I am currently seeking an experienced Clinical and Quality Operations professional for a high-growth opportunity focused on the treatment of cancer.

This is a new role and will lead a newly formed team supporting the Clinical and Quality business units. This position will have a hands-on focus initially that will transition to more people management and strategy as the company grows.

In this position, you will:

  • Contribute to strategic roadmap for electronic application platforms supporting the Clinical and Quality business functions.
  • Oversee Clinical and Quality applications, as needed.
  • Provide leadership and subject matter expertise on projects to ensure successful delivery outcomes.
  • Take responsibility for developing, interpreting, reviewing, validating, documenting and maintaining functional requirements.
  • Hire and manage staff, including planning and prioritization of workload, training, and performance review
  • Coordinate GXP system validation, where applicable.

Highly qualified applicants will have:

  • 5+ years of related work experience managing clinical and/or quality applications in a commercial-stage pharmaceutical company (or equivalent)
  • Bachelor’s degree (scientific, business, or technical subjects preferred) or equivalent experience
  • Experience with electronic applications used in clinical trials such as (EDC) IRT, Clinical Supply Chain, eTMF, CTMS).
  • Experience with Software Development Life Cycle (SDLC) and Computer System Validation
  • Experience and understanding of regulatory and compliance needs related to clinical systems such as 21 CFR Part 11, ICH GCP guidance, GDPR, etc.
  • Experience with electronic applications used for Quality Systems such as QMS
  • Managerial experience highly preferred
  • Veeva certification is preferred

This position is a priority hire and will move quickly, interested candidates should submit resumes ASAP to be considered.

Senior Manager, Clinical and Quality (IT) Applications – High Growth Oncology Biotech – Seattle, WA

 

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