Job Description Summary

The Clinical Biospecimen Senior Scientist is 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.

 

Job Description

• 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.

• Ensure proper escalation of any identified trial specific risks and issues related to biospecimen collection and analysis in conjunction with relevant line functions.

• Collaborate 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.

• Implementation of and compliance to standards (SOPs) and best practices within assigned clinical trial(s) and within clinical program(s), including sharing lessons learned

Essential criteria:

• Advanced degree in life sciences strongly preferred, BS or BA in life sciences with relevant experience required

• English language (written and oral)

Desirable criteria:

• Familiarity with standard sample testing methodologies, assay technologies, and molecular biology

• At least 2 years of 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

 

Skills Desired

Budget Management, Clinical Research, Clinical Trial Protocol, Clinical Trials, Coaching, Data Analysis, Data Integrity, Learning Design, Lifesciences, Risk Monitoring, Trends Analysis