Bioanalytical Study Manager

Thermo Fisher Scientific UK

Remote, US
Remote
Bioanalytical operations management
Vendor management for lab services
Study document finalization
Thermo Fisher Scientific is seeking a remote Bioanalytical Study Manager to oversee bioanalytical operations for pre-clinical studies and clinical trials. The role involves managing vendor relationships, coordinating study activities, and ensuring data accuracy while working closely with clinical teams and third-party lab providers

Job Summary

  • Manage bioanalytical operations for pre-clinical studies and clinical trials, ensuring timely delivery of quality data by coordinating activities between multiple stakeholders.
  • Support the team contracting with third-party lab service providers for assay development and validation, collaborating with business operations, procurement, and clinical teams.
  • Provide input into clinical trial documents and drive the delivery of data transfer specifications, ensuring data accuracy.

Matching Summary

Match Score: 85

Thermo Fisher Scientific is seeking a remote Bioanalytical Study Manager to oversee bioanalytical operations for pre-clinical studies and clinical trials. The role involves managing vendor relationships, coordinating study activities, and ensuring data accuracy while working closely with clinical teams and third-party lab providers.

Skills & Requirements

Must-have

  • Bioanalytical operations management
  • Vendor management for lab services
  • Study document finalization
  • Sample analysis tracking
  • Large molecule immunoassay experience
  • PK/ADA assay experience

Nice-to-have

  • Translational or biomarker experience
  • Biomarker techniques experience
  • Flow cytometry experience
  • Multicolor panel design
  • Compensation and gating strategy
  • FlowJo data analysis

Key Requirements

  • BA/BS in a scientific degree + 2 years experience
  • Experience in a regulated environment
  • Understanding of clinical trial design
  • Good project management background
  • Strong communication and collaboration skills
  • Must be legally authorized to work in the United States without sponsorship

Work Rights

Must be legally authorized to work in the United States without sponsorship

Tailored Resume

Cover Letter