Bioanalytical Study Manager-REMOTE

Thermo Fisher Scientific Inc.; Agawam (MA); Remote; USD 60,000 - 100,000; Full time

Job summary

An innovative company is seeking a Bioanalytical Study Manager to lead bioanalytical operations for clinical trials. In this role, you'll coordinate with various stakeholders to ensure the timely delivery of quality data, manage vendor relationships, and oversee sample logistics. This position offers a collaborative environment where you can contribute to impactful clinical research and enjoy opportunities for professional growth. If you're passionate about making a difference in bioanalysis, this role is for you.

Benefits

Professional Growth Opportunities

Collaborative Work Environment

Impactful Work on Clinical Trials

Qualifications

• 2+ years of experience in a bioanalytical laboratory.
• Experience in a regulated environment and understanding of clinical trial design.

Responsibilities

• Manage bioanalytical operations for pre-clinical studies and clinical trials.
• Coordinate activities between stakeholders to ensure timely delivery of quality data.

Skills

Organizational Skills

Analytical Skills

Written Communication

Verbal Communication

Excel Proficiency

Education

BA/BS in a Scientific Degree

Tools

Excel

Job description

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!