Souhrn
About the Role
Your responsibilities include, but are not limited to:
- Independently provide operational support to Biomarker Study Experts and clinical studies focusing on biomarker samples and including reviews of clinical study protocol, preparing site operations manuals, informed consent forms, sample collection table, instruction manual, central lab protocol/manual, and eCRF and other biomarker sample operation logistics and coordination including study setup, sample tracking/reconciliation, assay and vendor set up, sample/data upload and study closure
- Support 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
- Independently identify and resolve sample management and sample discrepancy issues
- Identify, and escalate issues, ESP, quality or performance issues and engage LF experts/SME, clinical trial leaders and data management as needed.
- Contribute to the best practices, process.
- Continuous improvement initiatives and innovations in sample management functions
- Collaborate with other TM, BMD and GCO functions
- BS in life science with 4+ years of clinical operations experiences and/or clinical bioanalysis and/or clinical biomarkers. Advance degree with 2 years in clinical operations and/or clinical bioanalysis and/or clinical biomarkers
- Operational knowledge of clinical trials: clinical study set up, clinical sample management, clinical sample analysis and managing external service provider (ESP) including central laboratories and/or specialized vendors
- Laboratory background and knowledge immunoassay and/or bioanalysis
- Knowledge of the drug development process, clinical biomarkers and working with translation clinical research.
- Strong project and time management skills, problem solving, communication and leadership skills.
- Knowledge of regulatory requirements e.g. ICH/GCP, GLP, etc.
WHY NOVARTIS
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
