Work Schedule

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Job Description

Location: Home-based, UK or Sweden

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.

With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to use the experience of our staff, while allowing you, the employee, to gain direct experience working with a pharmaceutical/biopharmaceutical company, all while maintaining full-time benefits.

Role Overview

As a Senior Bioanalytical Study Manager, you’ll manage bioanalytical operations for pre-clinical studies and clinical trials, ensuring the timely delivery of high-quality data by coordinating activities across multiple internal and external stakeholders.

This role will have a particular focus on high-priority, late-phase clinical studies, requiring a strong understanding of the complexities associated with late-phase clinical development and the regulatory environment.

Key Responsibilities

• Vendor Management: 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 ensure appropriate SOWs and contracts are established.
• Study Coordination: Manage bioanalytical activities across clinical studies, including critical reagent supply and sample analysis. Work closely with bioanalytical strategy leads, clinical trial teams and laboratory service providers to finalize study documentation and ensure delivery against study timelines.
• Bioanalytical Oversight: Coordinate bioanalytical activities involving both LC-MS and ligand-binding assay (LBA) platforms, supporting the analysis of small- and large-molecule therapeutics as appropriate.
• Late-Phase Clinical Development: Support complex, high-priority late-phase clinical studies, applying an understanding of clinical trial design, operational requirements and the challenges associated with later-stage development.
• Regulatory Support: Apply strong regulatory awareness to bioanalytical study activities and documentation, ensuring work is conducted in accordance with applicable regulatory expectations and requirements.
• Documentation & Data: Provide input into clinical trial documents, including eCRFs, ICFs and SOWs. Drive the delivery of data transfer specifications and ensure the quality, accuracy and timely delivery of bioanalytical data.
• Sample Logistics: Track and reconcile clinical samples and associated testing, proactively identifying and resolving issues that could impact study timelines or data delivery.
• Biomarker Activities: Support biomarker-related bioanalytical activities where required, working across relevant internal teams and external laboratory partners.

Qualifications

Education

• 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

• 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; candidates with a mixed LC-MS/LBA background are particularly encouraged.
• Experience supporting the bioanalysis of small and/or large molecules, with the ability to work effectively across different bioanalytical platforms.
• Strong regulatory awareness, particularly as it relates to bioanalytical activities supporting clinical development.
• Experience with biomarker bioanalysis
• Experience with PK and/or immunogenicity/ADA bioanalysis is advantageous.
• Experience with additional biomarker techniques and/or flow cytometry would be beneficial.
• Experience coordinating external laboratories/CROs and multiple stakeholders within complex clinical programs is preferred.

Skills

• 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.

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

 
Benefits

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!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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