Senior Bioanalytical Study Manager – Client-dedicated

Job not on LinkedIn

🔥 0 minutes ago

🌐 United Kingdom, Sweden – Remote

🇬🇧 United Kingdom – Remote 🇸🇪 Sweden – Remote

⏰ Full Time

🟠 Senior

🤝 Client Partner

👻 Ghost score 10%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Manage bioanalytical operations for pre-clinical studies and clinical trials • Coordinate activities across multiple internal and external stakeholders to ensure timely delivery of high-quality data • Support contracting activities with third-party laboratory service providers for assay development, validation and sample analysis • Collaborate with business operations, procurement, clinical teams and external laboratories to establish appropriate SOWs and contracts • Manage bioanalytical activities across clinical studies, including critical reagent supply and sample analysis • Work with bioanalytical strategy leads, clinical trial teams and laboratory service providers to finalize study documentation and deliver against study timelines • Coordinate bioanalytical activities involving LC-MS and ligand-binding assay platforms • Support complex, high-priority late-phase clinical studies • Apply regulatory awareness to bioanalytical study activities and documentation • Provide input into clinical trial documents, including eCRFs, ICFs and SOWs • Drive delivery of data transfer specifications and ensure quality, accuracy and timely delivery of bioanalytical data • Track and reconcile clinical samples and associated testing, resolving issues affecting study timelines or data delivery • Support biomarker-related bioanalytical activities across internal teams and external laboratory partners

🎯 Requirements

• BA/BS in a scientific discipline plus at least 2 years of relevant project or study management experience within a bioanalytical laboratory or related environment • Experience working in a regulated bioanalytical, pharmaceutical or clinical development environment • Strong understanding of clinical trial design and clinical development, ideally including experience supporting late-phase clinical studies • Demonstrated understanding and practical experience with LC-MS (liquid chromatography-mass spectrometry) bioanalysis • Experience with ligand-binding assays (LBA) and large-molecule bioanalysis is highly desirable • Experience supporting the bioanalysis of small and/or large molecules • Strong regulatory awareness, particularly as it relates to bioanalytical activities supporting clinical development • Experience with biomarker bioanalysis • Strong organizational, project management and analytical skills • Ability to manage multiple priorities in a fast-paced, high-priority clinical development environment • Excellent written and verbal communication skills • Strong stakeholder and vendor management capabilities • Ability to work both independently and collaboratively within cross-functional teams • Strong attention to quality, timelines and regulatory requirements • Proficiency with Excel and other relevant data and project management tools

🏖️ Benefits

• Competitive remuneration • Annual incentive plan bonus • Healthcare • Full-time benefits • Opportunities for learning and development • Employee benefits • Exciting company culture • Accessibility service or accommodation support during the job application process for job seekers with disabilities