Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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 onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits

Role Overview:

As a Bioanalytical Study Manager you'll manage bioanalytical operations for pre-clinical studies and clinical trials, ensuring timely delivery of quality data by coordinating activities between multiple stakeholders.

This position is home based in the UK or home based in Sweden. Our client has sites in Cambridge and Stockholm, so hybrid working can also be accommodated if preferred.

Key Responsibilities:

• Vendor Management: Support the team 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.

• 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.

Qualifications:

Education:

• BA/BS in a scientific degree + 2 years’ project management experience in a Bioanalytical laboratory.

Experience:

• Experience of working in a regulated environment

• Understanding of clinical trial design

• Strong large-molecule immunoassay-based bioanalysis experience, ideally with translational or biomarker expertise

• Experience performing PK/ADA assays is required

• Experience with biomarker techniques and/or flow cytometry is preferred

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.

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. #Start Your Story 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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