TMF Integration Oversight Manager | Novartis – East Hanover, NJ, USA
Job Summary:
Novartis is hiring a TMF Integration Oversight Manager to lead clinical documentation planning and transition activities in support of mergers, acquisitions, and licensing projects. Located at the East Hanover, New Jersey site (on-site only), this role offers the opportunity to work within the Clinical Document Governance Management (CDGM) team and help shape the future of clinical document management across global development programs.
Key Responsibilities:
Serve as the primary CDGM contact for in-licensing, out-licensing, and acquisition/divestment projects.
Develop and manage comprehensive TMF transition plans for both paper and electronic documentation.
Collaborate with cross-functional teams including Legal, Development QA, and Informatics.
Identify documentation risks and define corrective actions with stakeholders.
Oversee vendor performance and service delivery against TMF transition objectives.
Act as SME for TMF training materials and support documentation tools and processes.
Support audits, inspections, and CAPA development.
Assist the TMF Integration Lead with forecasting and project planning.
Required Skills & Qualifications:
Bachelor’s degree or equivalent experience in a life sciences field.
Minimum 5 years of experience in clinical research or documentation within pharma or CRO settings.
Proven track record managing cross-functional projects in clinical development.
Strong stakeholder communication, negotiation, and influence skills.
High organizational awareness with global team collaboration experience.
Fluent in English; strong documentation and presentation skills.
Perks & Benefits:
Salary Range: $114,100 – $211,900 per year
Eligibility for sign-on bonus, stock units, and discretionary awards
Comprehensive medical, financial, and life insurance benefits
401(k) with company match
Paid time off: vacation, sick leave, parental leave
Inclusion in Novartis's professional growth and development programs
Company Description:
Novartis is a global pharmaceutical leader dedicated to advancing healthcare innovation. With a strong focus on digital transformation and data-driven drug development, Novartis empowers talented professionals to deliver next-generation therapies to patients around the world.
Work Mode:
On-site – East Hanover, NJ
Relocation is not offered. Only local candidates will be considered.
Call-to-Action:
Ready to lead TMF transitions and contribute to global drug development excellence? Join Novartis as a TMF Integration Oversight Manager and help revolutionize clinical document governance. Apply today and become a key part of our mission to reimagine medicine.
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