Senior Bioanalytical Study Manager - Client-dedicated - FSP

Work Schedule Standard (Mon-Fri) Environmental Conditions Office 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.

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.

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.

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 working in a regulated bioanalytical, pharmaceutical or clinical development environment. Strong understanding of clinical trial design and clinical development, ideally including experience