Summary

Summary Title: TMF Integration Oversight Manager

The ideal location for this role is East Hanover, NJ but remote work may be possible (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. If associate is remote, all home office expenses and any travel/lodging to East Hanover, NJ site for periodic live meetings will be at the employee’s expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require limited travel.


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.