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Hybrid Senior Bioanalytical Study Manager presso Thermo Fisher

Thermo Fisher · Agawam, Massachusetts, USA, Stati Uniti d'America · Hybrid

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Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Bioanalytical Study Manager

Role Overview:

Join our dynamic team and lead the charge in supporting AstraZeneca's Development pipeline from a bioanalytical perspective. You'll manage bioanalytical operations for pre-clinical studies and clinical trials, ensuring timely delivery of quality data by coordinating activities between multiple stakeholders.

Key Responsibilities:

  • Vendor Management: Support the team contracting with third-party lab service providers for assay development and validation. Collaborate with business operations, procurement, and clinical teams to ensure appropriate SOWs and contracts.
  • Study Coordination: Manage critical reagent supply and sample analysis. Work closely with bioanalytical strategy leads, clinical trial teams, and lab service providers to finalize study documents and meet timelines.
  • Documentation & Data: Provide input into clinical trial documents (e.g., eCRFs, ICFs, SOWs). Drive the delivery of data transfer specifications and ensure data accuracy.
  • Sample Logistics: Track and reconcile sample testing, resolving any issues that arise.

Qualifications:

  • Education: BA/BS in a scientific degree + 2 years’ experience in a Bioanalytical laboratory.
  • Experience:
    • Experience of working in a regulated environment
    • Understanding of clinical trial design
  • Skills:
    • Strong organizational and analytical skills.
    • Excellent written/verbal communication.
    • Ability to work both independently and as part of a team.
    • Proficiency with Excel and other interactive programs.

Why Join Us?

  • Innovative Environment: Work on cutting-edge projects in a collaborative setting.
  • Professional Growth: Opportunities for learning and development.
  • Impactful Work: Contribute to life-changing clinical trials and research.

Apply Now and Make a Difference in Bioanalysis!

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