TMF Oversight Manager

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When we put our heads together, we can do brilliant work. And when we do brilliant work, we can achieve remarkable things for patients as we positively transform healthcare.

Trial Master File (TMF) Oversight Manager

Join our existing global team. The TMF Oversight Manager is responsible for ensuring delivery and oversight of high quality and timely TMF Quality Review activities for a portfolio of internal, outsourced, or BD&L studies. You will drive the implementation of Clinical Document Governance Management initiatives, projects, and process improvement activities to enhance clinical document management systems, processes, and standards at Novartis. Responsibilities include, but are not limited to:

• Responsible for timely assessment of quality and completeness of TMFs for an assigned portfolio of studies.

• Identify and communicate TMF risks/trends/patterns and work with key stakeholders to define and implement pragmatic remediations.

• Execute vendor oversight plan, monitor service metrics, and identify opportunities for improvement to the operating model. Act as a point of escalation for issues.

• Serve 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 stakeholders.

• Provide Audit/Inspection readiness support by driving TMF quality reviews in preparation for audits/inspections, contribute to root cause analysis identification and creation/delivery of CAPAs.

• Identify and implement improvements to document management processes to improve the quality of TMFs. May act as business lead for innovation projects to enhance TMF quality assessment.

• Support 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.

• Support the definition and refinement of TMF management strategy for assigned portfolio of studies. Ensure clear expectations for TMF setup and maintenance, including contractual agreement with third parties, for outsourced studies.

• 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 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.