Senior Bioanalytical Study Manager – Client-dedicated

This is a fully remote position, open to applicants in United Kingdom, +1 more country.

📋 Description

• Oversee bioanalytical operations for pre-clinical studies and clinical trials.

• Coordinate activities among various internal and external stakeholders to ensure the timely delivery of high-quality data.

• Assist in contracting processes with third-party laboratory service providers for assay development, validation, and sample analysis.

• Collaborate with business operations, procurement, clinical teams, and external laboratories to create appropriate SOWs and contracts.

• Manage bioanalytical activities throughout clinical studies, including critical reagent supply and sample analysis.

• Work alongside bioanalytical strategy leads, clinical trial teams, and laboratory service providers to finalize study documentation and meet study timelines.

• Coordinate bioanalytical activities involving LC-MS and ligand-binding assay platforms.

• Support complex, high-priority late-phase clinical studies.

• Apply regulatory knowledge to bioanalytical study activities and documentation.

• Contribute to clinical trial documents, including eCRFs, ICFs, and SOWs.

• Ensure the delivery of data transfer specifications while maintaining quality, accuracy, and timely reporting of bioanalytical data.

• Monitor and reconcile clinical samples and associated testing, addressing issues that impact study timelines or data delivery.

• Assist with biomarker-related bioanalytical activities across both internal teams and external laboratory partners.

⛳️ Requirements

• BA/BS in a scientific field, along with a minimum of 2 years of relevant project or study management experience within a bioanalytical laboratory or similar environment.

• Experience in a regulated bioanalytical, pharmaceutical, or clinical development setting.

• Strong comprehension of clinical trial design and clinical development, ideally with experience supporting late-phase clinical studies.

• Proven understanding and hands-on experience with LC-MS (liquid chromatography-mass spectrometry) bioanalysis.

• Experience with ligand-binding assays (LBA) and large-molecule bioanalysis is highly preferred.

• Background in supporting the bioanalysis of small and/or large molecules.

• Strong regulatory insight, particularly concerning bioanalytical activities that support clinical development.

• Experience with biomarker bioanalysis.

• Excellent organizational, project management, and analytical capabilities.

• Ability to handle multiple priorities in a dynamic, high-stakes clinical development environment.

• Superior written and verbal communication skills.

• Strong stakeholder and vendor management skills.

• Capability to work both independently and collaboratively within cross-functional teams.

• Keen attention to quality, timelines, and regulatory compliance.

• Proficient in Excel and other relevant data and project management tools.

🏝️ Benefits

• Competitive remuneration.

• Annual incentive plan bonus.

• Healthcare benefits.

• Comprehensive full-time benefits.

• Opportunities for professional learning and development.

• Employee benefits program.

• Vibrant company culture.

• Accessibility services or accommodation support during the job application process for candidates with disabilities.