TMF Integration Oversight Manager
TMF Integration Oversight Manager
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$ 114100 - 211900
1 Vacancy
Job Description
Band
Level 4Job Description Summary
Title: TMF Integration Oversight ManagerThis position will be located at East Hanover NJ site and will not have the ability to be located remotely.
Please note that this role would not provide relocation and only local candidates will be considered.
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.
The TMF Oversight Integration Manager ensure successful planning and transition of TMF documentation to and from Novartis in support of Mergers & Acquisition (M&A) projects and Out licensing activities. Drives implementation of CDGM initiatives projects and process improvement activities to enhance clinical document management systems processes and standards at Novartis.
#LI-Hybrid
Key Responsibilities:
Major accountabilities but not limited to:
Act as CDGM point of contact for assigned portfolio of In-Licensing / Out-Licensing / Acquisition / Divestment Projects collaborating with key stakeholders with CDGM teams Development Informatics Legal Development Quality Assurance and Global Project Teams.
Lead and/or Contribute to the development of TMF Transition Plans and ensure the successful transitions of TMF (paper and electronic) documentation outside of Novartis in support of out-licensing and divestment projects and into Novartis in support of in-licensing and acquisition projects.
Develop and maintain paper and electronic document processes & standards relating to M&A projects and Out licensing activities in compliance with internal and external requirements & regulations.
Identify and communicate risks/trends/patterns relating to TMF M&A projects Out licensing activities and work with key stakeholders to define and implement pragmatic remediations.
Executes vendor oversight plan monitors service metrics and identifies opportunities for improvement to the operating model. Acts as point of escalation for issues.
Serves as Subject Matter Expert on TMF transition related training materials formal and informal processes and tracking tools for TMF transition oversight activities in collaboration with CDM Process team and other key stakeholders
Provides support for inspections/audits contributes to root cause analysis identification and creation/delivery of CAPAs.
Supports the TMF Integration Lead with respect to forecasting and planning of M&A projects.
Job Description
Requirements:
- Bachelors 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 executing cross functional projects.
- Strong influencing and presentation skills. Ability to communicate effectively 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 stakeholders.
- Fluent in English
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $114100/yr and $211900/yr; however while salary ranges are effective from 1/1/25 through 12/31/25 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.
Company will not sponsor visas for this position.
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. 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 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
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 call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Range
Skills Desired
Budget Management Clinical Trials Negotiation Skills Process Improvement Project Planning Vendor Management Waterfall ModelRequired Experience:
Manager
Employment Type
Full-Time
