Summary
About the Role
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.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
