387172BR
Nov 20, 2023
USA
About the Role
Clinical Document Governance Management (CDGM) is accountable for strategy and delivery of clinical document management (CDM) systems, processes, standards and operations of CDM services (including Trial Master File management (TMF), clinical submission readiness, record retention and archiving, Good Documentation Practice capability build) across Novartis globally. In addition, CDGM is driving the transformation of TMF at Novartis, through the introduction and adoption of new technologies, processes and ways of working.
But in this world of digital and technological transformation, we must also continue to evolve our approaches to clinical document management and unleash the power of information from this expanding universe of data.
Your responsibilities include but not are limited to:
• Delivery of high quality and timely TMF Quality Review activities for a portfolio of internal
studies.
• Drive implementation of CDGM initiatives, projects and process improvement activities to enhance clinical document management systems, processes and standards at Novartis.
• Responsible for timely assessment of quality and completeness of TMFs for an assigned portfolio of studies. Identifies and communicate TMF risks/trends/patterns and works with key collaborators to define and implement pragmatic remediations.
• Executes vendor oversight plan, monitors service metrics and finds opportunities for improvement to the operating model. Acts as point of escalation for issues.
• Serves as Subject Matter Expert on TMF training materials, formal and informal processes and tracking tools for TMF oversight activities in collaboration with CDM Process team and other key collaborators
• Provides Audit/Inspection readiness support by driving TMF quality reviews in preparation for audits/inspections, contributes to root cause analysis identification and creation/delivery of CAPAs.
• Identify and implement improvements to document management processes to improve quality of TMFs. May act as business lead for innovation projects to enhance TMF quality assessment.
• Supports the forecasting and tracking of TMF Quality Review resource needs including proactive identification of resources to support TMF Quality Review activities for high-risk and priority projects
• Supports definition and refinement of TMF management strategy for assigned portfolio of studies. Ensures clear expectations for TMF set up and maintenance, including contractual agreement with third parties, for outsourced studies.
But in this world of digital and technological transformation, we must also continue to evolve our approaches to clinical document management and unleash the power of information from this expanding universe of data.
Your responsibilities include but not are limited to:
• Delivery of high quality and timely TMF Quality Review activities for a portfolio of internal
studies.
• Drive implementation of CDGM initiatives, projects and process improvement activities to enhance clinical document management systems, processes and standards at Novartis.
• Responsible for timely assessment of quality and completeness of TMFs for an assigned portfolio of studies. Identifies and communicate TMF risks/trends/patterns and works with key collaborators to define and implement pragmatic remediations.
• Executes vendor oversight plan, monitors service metrics and finds opportunities for improvement to the operating model. Acts as point of escalation for issues.
• Serves as Subject Matter Expert on TMF training materials, formal and informal processes and tracking tools for TMF oversight activities in collaboration with CDM Process team and other key collaborators
• Provides Audit/Inspection readiness support by driving TMF quality reviews in preparation for audits/inspections, contributes to root cause analysis identification and creation/delivery of CAPAs.
• Identify and implement improvements to document management processes to improve quality of TMFs. May act as business lead for innovation projects to enhance TMF quality assessment.
• Supports the forecasting and tracking of TMF Quality Review resource needs including proactive identification of resources to support TMF Quality Review activities for high-risk and priority projects
• Supports definition and refinement of TMF management strategy for assigned portfolio of studies. Ensures clear expectations for TMF set up and maintenance, including contractual agreement with third parties, for outsourced studies.
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
Key Requirements:
• Bachelor’s degree or equivalent and relevant industry experience.
• Minimum of 5 years working in clinical research and development in the pharmaceutical industry (and/or Contract Research Organizations) with specific experience in clinical documentation and/or records & information management.
• Demonstrated success in planning and driving cross functional projects.
• Strong influencing and presentation skills. Ability to communicate optimally at all levels.
• High organizational awareness, including experience working in multi-disciplinary teams, across cultures and geographies.
• Good negotiation, problem solving and conflict resolution skills; experience establishing trusted relationships with internal and external customers.
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.
The pay range for this position at commencement of employment is expected to be between $118,400 and $177,600/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:
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
• Bachelor’s degree or equivalent and relevant industry experience.
• Minimum of 5 years working in clinical research and development in the pharmaceutical industry (and/or Contract Research Organizations) with specific experience in clinical documentation and/or records & information management.
• Demonstrated success in planning and driving cross functional projects.
• Strong influencing and presentation skills. Ability to communicate optimally at all levels.
• High organizational awareness, including experience working in multi-disciplinary teams, across cultures and geographies.
• Good negotiation, problem solving and conflict resolution skills; experience establishing trusted relationships with internal and external customers.
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.
The pay range for this position at commencement of employment is expected to be between $118,400 and $177,600/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:
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
Development
GCO GDD
USA
East Hanover, NJ
Novartis Pharmaceuticals
Research & Development
Full Time
Regular
No
387172BR