Job Description Summary When we put our heads together, we can do brilliant work. And when we do brilliant work, we can achieve remarkable things for patients as we positively transform healthcare. We are looking for Clinical Biospecimen, Senior Scientist to join our existing global team.
The Clinical Biospecimen, Senior Scientist is responsible for the implementation and end-to-end operational execution of each Global Clinical Operations clinical trial strategy as it relates to all biospecimens collected, including safety, pharmacokinetics, biomarkers for clinical trials of standard to medium complexity, in compliance with Novartis processes and regulatory and ethical requirements. You may support specific aspects related to companion diagnostics.
This is a hybrid role and can be based in Dublin or London offices. The expectation is to be in the office 12 days/month.
Job Description Your responsibilities include, but are not limited to: Provide input on clinical sample assessment sections in clinical trial-related documents (such as protocols and consents) in collaboration with the LF representatives.Create study-specific sample collection tables and ensure alignment with blood volumes needed versus allowed.Liaise with internal stakeholders to provide input into the SSW's for all biospecimen collection and testing needs.Responsible to set up and oversee the technical aspects for all laboratories involved in kit building, sample management, and testing, including all related documentation such as lab manuals.Provide input and solutions on the ethical considerations for biospecimen collections and analyses for protocols and consents to ensure that all specific processes needed for approval in different countries are implemented.Responsible for sample management and logistics, with some oversight from the Lead CBS, throughout the biospecimen lifecycle; this includes ensuring timely analysis, proper consent, and oversight of samples, in collaboration with data management.Define sample needs for the case report forms (CRFs) and data transfer in collaboration with internal stakeholders/LF representatives, trial clinical data scientist (TCDS) and analysis labs; with support, liaise with the TCDS and labs for data transfer and data reconciliation.Support the development of training material on the technical aspects of biospecimen collections for the clinical trial sites, including study specific lab manuals and additional site and monitor training needs.Ensure proper handling of all study close out activities related to biospecimens and laboratories, including sample disposition (disposal, return, storage).Ensure proper escalation of any identified trial specific risks and issues related to biospecimen collection and analysis in conjunction with relevant line functions.In collaboration with vendor management and procurement, with some oversight from the Lead CBS, review all laboratory proposals and provide budget input for the trial forecast; review invoices.In collaboration with vendor management, manage relationships with labs.Responsible for implementation of and compliance to standards (SOPs) and best practices within assigned clinical trial(s) and within clinical program(s), including sharing lessons learned.Minimum requirements Advanced degree in life sciences strongly preferred, BS or BA in life sciences with relevant experience required.At least 2 years of experience handling diverse type of clinical samples.Familiarity with standard sample testing methodologies, assay technologies, and molecular biology.Knowledge of GCP; intermediate knowledge of GLP and ICH.Intermediate knowledge of clinical trial design and the overall drug development process.Excellent organizational and communication skills.Ability to manage multiple competing priorities and meet timelines.Why Novartis? Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!
You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams 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.
Skills Desired: Clinical Trials, Data Management, Sample Collection, Sample Management, Vendor Management.
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