Senior Scientist

Key Accountabilities   

• Provide operational support to clinical studies focused on biomarkers, safe-ty and PK samples, including clinical study setup, sample tracking/reconciliation, assay and vendor coordination, sample/data upload support and study closure activities. Responsibilities include supporting the re-view of clinical study protocols, site operations manuals, informed consent forms, sample collection tables, instruction manuals, central lab proto-col/manual, eCRF-related content, and other biomarker sample operation logistics. 
• Serve as a BMD Study Coordinator/ and clinical team representative from BMD on selected clinical studies and/or at a project level.
• Partner with clinical teams, data management, central labs, vendors, and internal functions to support biomarker and PK sample related activi-ties.Independently set up central lab and central lab services (specifications, clinical sites, samples, assays),
• Implement and monitor biomarker/PK sample flow across BM modalities (e.g., Immunoassay, LC-MS, Flow cytometry, genetics etc.) and PK assays
• Maintain and update study and project information in relevant reports, trackers, dashboards, and IT systems.
• Identify and escalate sample management, assay, vendor, data, quality or performance-related issues and to senior team members, subject matter experts, clinical trial leaders, and data management teams as appropriate.
• Contribute to process improvements, best practices, process and continuous improvement initiatives within sample, vendor, data and assay monitoring activities.
• Collaborate across Translational Medicine functions, central lab, clinical sites, and vendors to support efficient study execution, aligning with defined LEO processes. 

Essential Requirement