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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
Key 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 Coordinator / BMD Study Expert 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, quality or performance issues and engage LF experts/SME, clinical trial leaders and data management as needed.
- Lead best practices, process and continuous improvement initiatives and innovations in sample, vendor, data and assay monitoring function
- Collaborate with across TM functions, lead site, central lab and vendors processes, drives continuous improvement initiatives and innovations in LEO
Essential Requirement
- Education: Master’s degree (M.Sc.) in Life Sciences or advanced degree in Clinical Operations, Clinical Bioanalysis, Biomarkers, or related field, with ~3+ years of relevant clinical operations experience.
- Language: Fluent in English (written and spoken) for global collaboration.
- Clinical Operations Knowledge: Strong understanding of clinical trial processes including study start-up, central lab setup, sample management, clinical data flows (e.g., DTS), and management of external service providers (labs/vendors).
- Technical & Functional Expertise: Laboratory background with knowledge of bioanalysis preferred; understanding of drug development, clinical biomarkers, clinical data management, and translational research is an advantage.
- Global & Matrix Experience: Experience working in global organizations and complex matrix environments with multiple stakeholders and cross-functional interfaces.
Skills Desired
Analytical Skill, Analytical Skill, Analytical Thinking, Chemical Biology, Chemistry, Clinical Research, Clinical Trials, Collaboration, Communication Skills, Curious Mindset, Data, Data Analysis, Design Of Experiments, Detail-Oriented, Diversity & Inclusion, Drug Discovery, Ethics, Gene Therapy, Immunology, Laboratory, Lifesciences, Machine Learning (ML), Mammalian Cell Culture, Medical Research, Molecular Biology {+ 11 more}