Clinical Biospecimen Senior Scientist

As a Clinical Bio-specimen Senior Scientist at Novartis, you will be responsible for the implementation and end-to-end operational execution of each GCO clinical trial strategy as it relates to all bio-specimens collected, including safety, pharmacokinetics, biomarkers, and companion diagnostics, in compliance with Novartis processes and regulatory and ethical requirements.
Your responsibilities:
With oversight from the Clinical Bio-specimen Lead Scientist, contribute to all technical and operational bio-specimen related matters for assigned projects in collaboration with internal team members and line function (LF) representatives.
Provide input on clinical sample assessment sections in clinical trial-related documents (such as protocols and consents) with the LF representatives.
• Build study-specific sample collection tables and ensure alignment with blood volumes needed versus allowed.
• Liaise with internal collaborators to provide input into the SSW’s for all bio-specimen collection and testing needs.
• Responsible to set up and supervise 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 bio-specimen 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 throughout the bio-specimen lifecycle; this includes ensuring timely analysis, accurate 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 collaborators/LF representatives, trial data manager (TDM) and analysis labs; With support, liaise with the TDM and labs for data transfer and data reconciliation.
• Collaborate with internal collaborators to establish analytical plans and review transferred data to ensure quality.
• Develop training material on the technical aspects of bio-specimen 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 bio-specimens and laboratories, including sample disposition (disposal, return, storage).
• In collaboration with EDO/vendor management, maintain relationships with labs.
• Ensure proper escalation of any identified trial specific risks and issues related to bio-specimen collection and analysis in conjunction with relevant line functions.
• Responsible for implementation of and compliance to standards (SOPs) and best practices for trial management within assigned clinical trial(s) and within clinical program(s) and Development Unit, including sharing lessons learned.

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Experience/Professional requirements:
• Advanced degree in life sciences strongly preferred, BS or BA in life sciences with relevant experience required
• Familiarity with sample testing methodologies, assay technologies, and molecular biology
• At least 2 years of experience handling clinical samples
• Knowledge of GCP/GLP and ICH
• Basic knowledge of clinical trial design; understanding of 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! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
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 here: https://talentnetwork.novartis.com/network