摘要
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. We are looking for Trial Master File (TMF) Oversight Manager to 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 implementation of Clinical Document Governance Management initiatives, projects and process improvement activities to enhance clinical document management systems, processes and standards at Novartis.
This is a hybrid role and can be based in Dublin or London offices. The expectation is to be in the office 12 days/month.
About the Role
Your 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 works with key stakeholders to define and implement pragmatic remediations.
- Execute vendor oversight plan, monitors service metrics, and identifies opportunities for improvement to the operating model. Acts as 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, 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.
- 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 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.
Minimum 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 Organisations) 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 organisational 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.
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: http://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. http://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.
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: http://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? http://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: http://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://www.novartis.com/careers/benefits-rewards
Innovative Medicines
London (The Westworks)
GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.
Dublin (NOCC), Ireland
Research & Development
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Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
