Senior Bioanalytical Study Manager - Client-dedicated - FSP
Core
Manage bioanalytical operations for pre-clinical studies and late-phase clinical trials, ensuring timely delivery of high-quality data by coordinating activities across internal and external stakeholders.
Role type
Senior Bioanalytical Study Manager
Builds
Bioanalytical data and study deliverables for pharmaceutical/biopharmaceutical clients
Domain
Life Sciences / Clinical Research / Bioanalysis
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
Vendor management, Study coordination, Bioanalytical oversight (LC-MS, LBA), Late-phase clinical development support, Regulatory compliance, Documentation & data management, Sample logistics, Biomarker activities
Preferred skills
PK/immunogenicity/ADA bioanalysis experience, Flow cytometry experience, CRO coordination experience
Technologies
LC-MS, LBA, Excel
Responsibilities
Support contracting activities with third-party laboratory service providers for assay development and validation; Manage bioanalytical activities across clinical studies including critical reagent supply and sample analysis; 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; Track and reconcile clinical samples and associated testing; Support biomarker-related bioanalytical activities
Seniority
Senior, hands-on IC
