Clinical Biospecimen Senior Scientist

Novartis; London; On-site; GBP 50,000 - 75,000; Full time

Job summary

A leading pharmaceutical company seeks a Clinical Biospecimen Senior Scientist to oversee the operational execution of clinical trial strategies. You will manage the lifecycle of biospecimens, ensure compliance with regulations, and collaborate with multiple stakeholders. Ideal candidates will have advanced life sciences degrees and strong organizational skills, contributing to significant advancements in patient care.

Qualifications

• Proficient in English with experience in clinical trials.
• Knowledge of GCP, GLP, ICH guidelines.
• Experience with sample testing methodologies.

Responsibilities

• Manage biospecimen lifecycle and ensure compliance.
• Collaborate with internal stakeholders for sample needs.
• Support ethical considerations in biospecimen protocols.

Skills

Leadership

Organizational Skills

Communication

Risk Management

Education

Advanced degree in life sciences

BS or BA in life sciences

Job description

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Summary

Responsible for the implementation and end-to-end operational execution of each GCO 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. May support specific aspects related to companion diagnostics.

Summary

Responsible for the implementation and end-to-end operational execution of each GCO 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. May support specific aspects related to companion diagnostics.

About The Role

Major accountabilities:

• With some oversight from the lead Clinical Biospecimen Scientist (CBS), contribute to all technical and operational biospecimen-related matters for assigned clinical studies of standard to medium complexity, in collaboration with internal stakeholders and line function (LF) representatives.
• Provide input on clinical sample assessment sections in clinical trial-related documents (such as protocols and consents) in collaboration with the LF representatives, including creating 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. 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. Ensure proper handling of all study close out activities related to biospecimens and laboratories, including sample disposition (disposal, return, storage).
• 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.
• Risk management: Ensure proper escalation of any identified trial specific risks and issues related to biospecimen collection and analysis in conjunction with relevant line functions.
• Resource management: 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.
• 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.
  
  

Work Experience

• Advanced degree in life sciences strongly preferred, BS or BA in life sciences with relevant experience required
• Professional level of English spoken and written
• Familiarity with standard sample testing methodologies, assay technologies, and molecular biology
• Good experience handling diverse type of clinical samples
• 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
  
  

Commitment To Diversity And Inclusion / EEO Paragraph

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve

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

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Pharmaceutical Manufacturing

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