389800BR
Mar 06, 2024
USA
About the Role
(this is a Remote Position)
The SSO Study Start-Up Team Lead is accountable for the governance and oversight of a study start-up team in a standalone country or OPC (operating country). The SSO Study Start-Up Team Lead is supporting the country/OPC SSU strategy and prioritization in close collaboration with SSU/OPC Head and Country/OPC LT to deliver operational excellence of the GDD portfolio in compliance with Novartis processes, ICH/GCP and regulatory requirements.
Study Start-Up Strategy
• Supports Study & Site Operations Country Leadership Team to identify innovative practices to optimize country operations and operational excellence, especially in terms of study start-up activities to increase performance, productivity, and business impact
• Seeks and evaluates external knowledge and standard methodologies to enhance overall operational excellence of country trial operations
• Supports country SSU strategy in close collaboration with SSU/OPC Head and Portfolio Head/Portfolio Team Lead(s)
Allocation, initiation and conduct of trials
• Collaborates with Head Portfolio, SSO Portfolio Team Leads and global study team (Clinical Operations Program Head, Trial Lead) to ensure SSU timelines and results are met according to country commitments
• Accountable for timelines, accuracy, and quality of TMF documents, including study start-up and ongoing TMF maintenance to ensure TMF inspection readiness
• Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements
• Implements innovative and efficient processes which are in line with Novartis strategy
People and resource management
• Hiring, training, development, and retention of Study Start-Up associates
• Resource management and reporting of Study Start-Up associates
• Ensures associates have the required level of skills to successfully set-up and complete studies with high quality and according to business objectives
The SSO Study Start-Up Team Lead is accountable for the governance and oversight of a study start-up team in a standalone country or OPC (operating country). The SSO Study Start-Up Team Lead is supporting the country/OPC SSU strategy and prioritization in close collaboration with SSU/OPC Head and Country/OPC LT to deliver operational excellence of the GDD portfolio in compliance with Novartis processes, ICH/GCP and regulatory requirements.
Study Start-Up Strategy
• Supports Study & Site Operations Country Leadership Team to identify innovative practices to optimize country operations and operational excellence, especially in terms of study start-up activities to increase performance, productivity, and business impact
• Seeks and evaluates external knowledge and standard methodologies to enhance overall operational excellence of country trial operations
• Supports country SSU strategy in close collaboration with SSU/OPC Head and Portfolio Head/Portfolio Team Lead(s)
Allocation, initiation and conduct of trials
• Collaborates with Head Portfolio, SSO Portfolio Team Leads and global study team (Clinical Operations Program Head, Trial Lead) to ensure SSU timelines and results are met according to country commitments
• Accountable for timelines, accuracy, and quality of TMF documents, including study start-up and ongoing TMF maintenance to ensure TMF inspection readiness
• Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements
• Implements innovative and efficient processes which are in line with Novartis strategy
People and resource management
• Hiring, training, development, and retention of Study Start-Up associates
• Resource management and reporting of Study Start-Up associates
• Ensures associates have the required level of skills to successfully set-up and complete studies with high quality and according to business objectives
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
• A degree in scientific or health discipline required
• Minimum 5 years’ experience in clinical operations and planning Preferred
• Proven leadership capabilities and experience (with or without direct line management responsibilities).
• Understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoring
• Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health
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
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $151,200 - $226,800 year; 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.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
• Minimum 5 years’ experience in clinical operations and planning Preferred
• Proven leadership capabilities and experience (with or without direct line management responsibilities).
• Understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoring
• Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health
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
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $151,200 - $226,800 year; 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.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: 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
