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About the Role
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
- 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.
- Operational knowledge of clinical trials: clinical study set up, central lab set up, clinical sample management, clinical data flows (e.g. DTS) clinical sample analysis and managing external service provider (ESP) including central laboratories and/or specialized vendors
- Knowledge of the drug development process, clinical biomarkers, clinical data management and working with translation clinical research is a plus
- Strong global project management, proactive planning in clinical studies, problem solving, influencing, and communication skills.
- Knowledge of regulatory requirements e.g. ICH/GCP, GLP, etc
Desirable Requirement
- Laboratory background, knowledge of bioanalysis, are desired.
- Experience working in a global organization and matrix environment (multiple roles/connections and stakeholders) is a plus.
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.
