393801BR
Mar 07, 2024
USA
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
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.
Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:
Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:
- Novartis: e-mail [email protected] or call +1 (877)395-2339
- Sandoz: e-mail [email protected] or call: +1-609-422-4098
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
to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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
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 workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $174,000-$261,600/year; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
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
• 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
to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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
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 workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $174,000-$261,600/year; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
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
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
Development
GCO GDD
USA
East Hanover, NJ
Novartis Pharmaceuticals
Research & Development
Full Time
Regular
No
