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Clinical Biospecimen Expert Scientist
4 months ago
**About the Role**:
About the role:
Responsible for the implementation and end-to-end operational execution of GCO clinical trial strategy as it relates to all biospecimens collected, including safety, pharmacokinetics, biomarkers, and companion diagnostics, for clinical trials of all complexity levels, including highly complex trials, high priority trials and trials in which biospecimen activities are critical to study success (e.g. supporting patient selection or key study objectives), in compliance with Novartis processes and regulatory and ethical requirements.
Your Key Responsibilities:
1. Contribute independently to all technical and operational biospecimen-related matters for clinical studies of all complexity (including highly complex trials, high priority trials and trials in which biospecimen activities are critical to study success), 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.
- Create study-specific sample collection tables and ensure alignment with blood volumes needed versus allowed; align and optimize sample collection plans to simplify for patients and sites
- Liaise with internal partners to provide input into the SSW’s for all biospecimen 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 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 throughout the biospecimen lifecycle; this includes ensuring timely analysis, proper consent, and oversight of samples, in collaboration with data management.
- Ensure data management documents and tools are appropriately set-up for collecting biospecimen related data in case report forms (CRFs) and data transfer (including for complex/extensive molecular datasets), in collaboration with internal partners/LF representatives, Study Leaders, Trial Clinical Data Scientist (TCDS) and analysis labs; Liaise with the TCDS and labs for data transfer and data reconciliation.
- 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.
3. Resource management:
- In collaboration with vendor management and procurement, review all laboratory proposals and provide budget input for the trial forecast; review invoices.
- In collaboration with vendor management, maintain relationships with labs
**Diversity & Inclusion / EEO**:
- We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential._
**Role Requirements**:
- Advanced degree in life sciences strongly preferred, BS or BA in life sciences with relevant experience required
- Demonstrated expertise in various sample testing methodologies (including complex molecular methods), assay technologies, and molecular biology
- At least 4 years of experience balancing multiple types of clinical samples
- Knowledge of GCP; advanced knowledge of GLP and ICH
- Advanced knowledge of clinical trial design and the overall drug development process
- Basic knowledge on requirements/regulations associated with clinical diagnostics development
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
Commitment to Diversity & Inclusion: The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workp
