Principal Scientist, BMD Study Coordinator and BMD Study Expert (BSC/BSE) Biomarkers Development (BMD)

Job description

Job Description Summary Laboratory Excellence and Operation (LEO) and Biomarker Science and Operation (BSO) team in India are the key global resources for Line functions (LF) and Translational Medicine (TM) Clinical Trial Teams for biomarkers including biomarker outsourcing, scientific biomarker monitoring, vendor management, biomarker logistics, clinical site communication and sample coordination. LEO/BSO are working in close collaboration with clinical teams, LF technology experts, Biomarker Leads (BMLs) as well as external service providers (ESP) including central labs and clinical sites.  Job Description                   BR    ROLE PROFILE    General    Job Title:  Principal Scientist, BMD Study Coordinator and BMD Study Expert (BSC/BSE) Biomarkers Development (BMD)    Job Grade: Level 4    Department: BMD/ LEO    Reports to:  Jitesh Narayan Iyer          Job Purpose (State in one sentence the overall objective of the job)     Laboratory Excellence and Operation (LEO)  and Biomarker Science and Operation (BSO) team in India are the key global resources for Line functions (LF) and Translational Medicine (TM) Clinical Trial Teams for biomarkers including biomarker outsourcing, scientific biomarker monitoring, vendor management, biomarker logistics, clinical site communication and sample coordination. LEO/BSO are working in close collaboration with clinical teams, LF technology experts, Biomarker Leads (BMLs) as well as external service providers (ESP) including central labs and clinical sites.    Major Accountabilities      • Independently provide end to end operational support to clinical studies focusing on biomarkers and PK samples, clinical study setup, sample tracking/reconciliation, assay and vendor set up, sample/data upload and study closure. Specific steps include independent review of clinical study protocols, site operations manuals, informed consent forms, sample collection tables, instruction manuals, central lab protocol/manual, eCRF and other biomarker sample operation logistics and coordination including   • Serve as a BMD Study Expert BSE and clinical team representative from BMD on selected clinical studies and/or at a project level. Partner with clinical teams and functions  • Independently set up central lab and central lab services (specifications, clinical sites, samples, assays), implements and monitors biomarker/PK sample flow across BM modalities (e.g. Immunoassay, LC-MS, Flow cytometry, genetics etc.) and PK assays  • Partners with BMD SME to set up, implement biomarker assays at specialized external service providers (ESP) including data transfer and data flows in LIMS and DTS (e.g. study creation, data flow, data transfer, etc.) for managed biomarkers and studies. Update study and project information in relevant reports and IT systems  • Identify, escalate and resolve assay and sample management issues, ESP, q