Director, Clinical Document Management External TMF Operations

Sep 09, 2021
United Kingdom

Job Description

100,000 and more!

That’s how many patients are treated in our studies. And every year, 3 million documents are uploaded in the electronic Trial Master Files to preserve the story of the study and ensure innovative medicines can reach even more patients worldwide. But in this world of digital and technological transformation, we must also continue to evolve our approaches to clinical document management and unleash the power of information from this expanding universe of data.

The CDMT group is accountable for implementing and embedding document management systems, technologies and tools aligned and harmonised across business units enabling Novartis to meet its sponsor obligations on consistent, quality, readily accessible, inspection ready and available essential documentation in the shape of a Trial Master File (TMF) for human subject research studies.

Your responsibilities will include:
• Accountable for smooth operation and management of the TMF outsourcing model ensuring adequate capacity and capabilities at all times for effective delivery of science data/TMF when study conduct activities are not executed in-house (e.g. no Trial Monitoring Organization involvement) and the TMF is outsourced during study conduct
• Establishes a model for effective risk identification and mitigation for TMF record returns where the TMF is transferred back to Novartis from third-party vendors, Contract Research Organization or as part of asset in-licensing activities in collaboration with the External Development Operations (EDO) and Business Development & Licensing (BD&L) teams
• Drives the creation of robust and harmonized External TMF metadata mapping and filing specifications, based on the TMF Reference Model, ensuring the expectations for TMF set up, maintenance and return are set in Master Services Agreements/Work Orders with Third-Parties to ensure smooth data returns, reconciliation and integration of externally-generated records with the Novartis eTMF
• Establishes effective oversight and partnerships with Third Parties for consistent External TMF service delivery, with clearly defined metrics and performance targets and risk mitigations
• Continually scans and keeps sight of the evolving Regulatory landscape through proactive industry intelligence and fostering an external network
• Provides Audit/Inspection support, maintains credibility by building trusted relationships with the internal QA functions and Health Authorities inspectors and by delivering commitments and Corrective and Preventive Action plans on time
• Sets, reviews and evaluate annual performance objectives for the CDMX group in alignment with company goals
• Establishes the CDMX group, recruits, retains, manages, and develops associates in CDMX through coaching and feedback, talent reviews and other available Novartis resources and tools

The position can be location flexible to include Switzerland, UK, Ireland & US and as such, similar job postings will be advertised.

Minimum Requirements

What you'll need:
• Advanced degree or combination of bachelor’s degree in life-sciences/healthcare/pharmacy and relevant industry experience.
• Minimum of 10 years of 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.
• Minimum of 3 years’ experience in direct people management or matrix management of project/clinical teams.
• Deep understanding of drug development process, international drug approval procedures and standards (e.g. ICH-E3, ICH-E6, eCTD) and industry-wide standards in clinical document management (e.g. DIA TMF reference model).
• Demonstrated success in planning and executing cross functional change 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.

Commitment to diversity & inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

*Some restrictions on flexible working options may apply and will be discussed during interview if applicable.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:

Why consider Novartis?
799 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!
#LI-NOV = Novartis
Global Drug Development
United Kingdom
Research & Development
Full Time
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Director, Clinical Document Management External TMF Operations

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