Senior Bioanalytical Study Manager

🔥 1 hour ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

👔 Manager

👻 Ghost score 12%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Lead bioanalytical operations for pre-clinical studies and clinical trials • Coordinate activities among multiple stakeholders to ensure timely delivery of quality data • Contract with third-party laboratory service providers for assay development and validation • Collaborate with business operations, procurement, and clinical teams on SOWs and contracts • Manage critical reagent supply and sample analysis • Work with bioanalytical strategy leads, clinical trial teams, and laboratory service providers to finalize study documents and meet timelines • Support development of novel bioanalytical processes • Provide input into clinical trial documents, including eCRFs, ICFs, and SOWs • Drive delivery of data transfer specifications and ensure data accuracy • Track and reconcile sample testing and resolve issues • Contribute to cleaning and finalizing data

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification • 5+ years of comparable knowledge, skills, and abilities, or equivalent combination of education, training, and experience • Familiarity with clinical bioanalysis outsourcing operations • Knowledge of GLP and 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 • Experience supporting and managing small- and large-molecule studies, including LC-MS workflows • Flexibility across multiple analytical platforms and study types • Ability to handle multiple demanding programs simultaneously • Strong organizational and analytical skills • Excellent written and verbal communication • Ability to work independently and as part of a team • Proficiency with Excel and other interactive programs • Ability to work in laboratory and/or clinical environments • Ability to occasionally drive to site locations and travel domestically • Ability to use required personal protective equipment • Ability to work with potential exposure to biological fluids and infectious organisms

🏖️ Benefits

• Occasional domestic travel • Personal protective equipment provided/required, including protective eyewear, garments and gloves • Healthy and balanced work environment • Collaboration and development opportunities • Global team environment • Exposure and work support in laboratory and/or clinical environments

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