394018BR
Apr 29, 2024
USA
About the Role
Core member of the Clinical Trial Team (CTT), independently handling all clinical vendor-related aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. Accountable for vendor service delivery at study level. Collaborates closely with the Vendor Start-up Manager (VSM) for selected services (central labs, electronic clinical outcomes assessment/electronic patient reported outcomes (eCOA/ePRO), interactive response technology (IRT), cardiac and respiratory diagnostics, patient recruitment and retention (PR&R,) and imaging reading) during study start-up and leverages effectively their technical- and study start-up (SSU) expertise to ensure a timely study start-up. Proactively manages vendor-related risks and potential issues. Implements global vendor strategy and if required, raises vendor issues to the VSM or VCE while keeping Trial Lead and Vendor Program Leads informed about vendor risks and issues. Oversees vendor compliance at study level.
Accountabilities
Accountable for all clinical vendor related operational trial results, according to timelines, budget, operational procedures, quality/compliance and performance standards. Collaborates with the VSM for the VSM’s category specific responsibilities. Responsible for all activities for which no VSM is assigned with, and for all of the service deliveries after Study Start-up when the VSM is no longer assigned to the study.
Assigned responsibilities can include but are not limited to:
• Close interaction and collaboration with study Trial Lead and study team members during study lifetime
• Review of vendor related protocol sections during protocol development
• Collaborate with Vendor startup manager to the development of Study Specification Worksheet (SSW) to facilitate bid process. If no VSM is assigned to the category, drive the SSW completion.
• Manages collaborate with vendors in cooperation with vendor partner functions
• Quote/proposal review in collaboration with procurement, support contract negotiations, if required
• Contributes to the development of vendor contract amendments
• Accountable for Vendor cost control, budget review, invoice reconciliation and PO close-out
• Vendor service excellence at study level, ensures vendors meet quality and service level standards in their service delivery for the trial
• Covers all vendor activities after study start-up and all categories not covered by VSMs during start-up
• Initiates/Co-ordinates vendor kick-off meeting for categories not covered by VSMs
Accountabilities
Accountable for all clinical vendor related operational trial results, according to timelines, budget, operational procedures, quality/compliance and performance standards. Collaborates with the VSM for the VSM’s category specific responsibilities. Responsible for all activities for which no VSM is assigned with, and for all of the service deliveries after Study Start-up when the VSM is no longer assigned to the study.
Assigned responsibilities can include but are not limited to:
• Close interaction and collaboration with study Trial Lead and study team members during study lifetime
• Review of vendor related protocol sections during protocol development
• Collaborate with Vendor startup manager to the development of Study Specification Worksheet (SSW) to facilitate bid process. If no VSM is assigned to the category, drive the SSW completion.
• Manages collaborate with vendors in cooperation with vendor partner functions
• Quote/proposal review in collaboration with procurement, support contract negotiations, if required
• Contributes to the development of vendor contract amendments
• Accountable for Vendor cost control, budget review, invoice reconciliation and PO close-out
• Vendor service excellence at study level, ensures vendors meet quality and service level standards in their service delivery for the trial
• Covers all vendor activities after study start-up and all categories not covered by VSMs during start-up
• Initiates/Co-ordinates vendor kick-off meeting for categories not covered by VSMs
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
• Bachelor's degree or equivalent degree is required, with advanced degree preferred.
• 5+ years working experience and excellent knowledge of the clinical operation processes and vendor management preferred
• Excellent knowledge of GxP and ICH regulations
• Very good knowledge of clinical trial design and mapping to supplier requirements
• Thorough and technical understanding of Novartis specifications for supplier provided services
• User Acceptance testing for eCOA and IRT
• Site collaboration and site activation
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 $144,000-$216,000/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
• 5+ years working experience and excellent knowledge of the clinical operation processes and vendor management preferred
• Excellent knowledge of GxP and ICH regulations
• Very good knowledge of clinical trial design and mapping to supplier requirements
• Thorough and technical understanding of Novartis specifications for supplier provided services
• User Acceptance testing for eCOA and IRT
• Site collaboration and site activation
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 $144,000-$216,000/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
