386171BR
Apr 24, 2024
USA
About the Role
Love data management? Bring that passion to Novartis!
Multiple openings.
This key Principal Clinical Data Scientist will be responsible and accountable for managing all Data Management deliverables at a consistently high standard with respect to cost, quality, and timelines for all assigned indications within one or more Global Clinical Program(s)/Project(s).
Key Responsibilities:
• Provides DM leadership across assigned trial(s) and Program(s) ensuring strong DM representation across the CTT. Acts as an ambassador for CDAM across the organization, showcasing business value and benefits.
• Demonstrates a business understanding of the compound profile and data strategy to identify and assist in successful application of consistent data management processes and documentation across assigned programs, i.e. ensuring consistency across data quality plans
• Ensures alignment with the TA level data strategy as defined by the TA Data Strategy Director
• Competent in relevant CDISC or other recognized industry standards and how these impact the programming team. Ensures consistency of program level standards
• Maintains awareness of the status of start-up, conduct and finalization activities for all trials within assigned program(s) Tracks and requests necessary resources. Ensures the key study risks & issues are shared in the Project Review Meeting led by Sr GHs/GHs.
• Provides accelerated feedback to assure well written, stable protocols and amendments. Recognize and resolve protocol issues that may impact database
Multiple openings.
This key Principal Clinical Data Scientist will be responsible and accountable for managing all Data Management deliverables at a consistently high standard with respect to cost, quality, and timelines for all assigned indications within one or more Global Clinical Program(s)/Project(s).
Key Responsibilities:
• Provides DM leadership across assigned trial(s) and Program(s) ensuring strong DM representation across the CTT. Acts as an ambassador for CDAM across the organization, showcasing business value and benefits.
• Demonstrates a business understanding of the compound profile and data strategy to identify and assist in successful application of consistent data management processes and documentation across assigned programs, i.e. ensuring consistency across data quality plans
• Ensures alignment with the TA level data strategy as defined by the TA Data Strategy Director
• Competent in relevant CDISC or other recognized industry standards and how these impact the programming team. Ensures consistency of program level standards
• Maintains awareness of the status of start-up, conduct and finalization activities for all trials within assigned program(s) Tracks and requests necessary resources. Ensures the key study risks & issues are shared in the Project Review Meeting led by Sr GHs/GHs.
• Provides accelerated feedback to assure well written, stable protocols and amendments. Recognize and resolve protocol issues that may impact database
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
Essential Requirements:
• Bachelor’s degree in life science, computer science, pharmacy, nursing or closely related discipline.
• 4 years’ experience in Drug Development with at least 5+ years' in Clinical Data Management
• Demonstrated strong leadership, collaboration and organizational skills with proven ability to successfully manage simultaneous trials and meet deadlines
• Excellent understanding of clinical trials methodology, GCP and medical terminology
• Proven ability to interrogate and view data through various programming/GUI techniques.
• Must be able to anticipate challenges and risks and proactively suggest/implement solutions
• Ability to work under pressure demonstrating agility through effective and innovative team leadership
• Excellent interpersonal skills and proven ability to operate effectively in a global environment.
• Ability to influence and communicate across functions and to external stakeholders
• Understanding of project management concepts in order to aid delivery across a program
• Excellent oral and written skills
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
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. 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.
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:
https://talentnetwork.novartis.com/network
The pay range for this position at commencement of employment is expected to be: between $124,000 - $186,000; however, while salary ranges are effective from 1/1/24 through 12/31/24, 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.
Accessibility and reasonable accommodations:
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
• Bachelor’s degree in life science, computer science, pharmacy, nursing or closely related discipline.
• 4 years’ experience in Drug Development with at least 5+ years' in Clinical Data Management
• Demonstrated strong leadership, collaboration and organizational skills with proven ability to successfully manage simultaneous trials and meet deadlines
• Excellent understanding of clinical trials methodology, GCP and medical terminology
• Proven ability to interrogate and view data through various programming/GUI techniques.
• Must be able to anticipate challenges and risks and proactively suggest/implement solutions
• Ability to work under pressure demonstrating agility through effective and innovative team leadership
• Excellent interpersonal skills and proven ability to operate effectively in a global environment.
• Ability to influence and communicate across functions and to external stakeholders
• Understanding of project management concepts in order to aid delivery across a program
• Excellent oral and written skills
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
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. 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.
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:
https://talentnetwork.novartis.com/network
The pay range for this position at commencement of employment is expected to be: between $124,000 - $186,000; however, while salary ranges are effective from 1/1/24 through 12/31/24, 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.
Accessibility and reasonable accommodations:
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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
