QUALIFICATIONS:

Education: BA/BS or higher in medical science or a related field, plus 5+ years (BA/BS) or 2+ years (MS) of clinical trial management experience.
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

EXPERIENCE:

• Familiarity with clinical bioanalysis outsourcing operations.
• Knowledge of GLP, GCP guidelines, and vendor audits.
• Understanding of clinical trial design and data outputs.
• Experience with sample collection instructions and lab manuals.
• Proficiency in data transfer agreements/specifications and data reconciliation.

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.
  We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

ROLE OVERVIEW:

Join our dynamic team and lead the charge in supporting our client’s 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: Lead the 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. Support the development of novel Bioanalytical processes.
• 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. Contribute to cleaning and finalizing data.