Clinical Document Management Technology Team Lead

2 weeks ago

West London, United Kingdom Novartis Full time

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 CDM Technology Team Lead is accountable for effective planning, delivery and operational oversight of Clinical Document Management and Interfacing systems used for management of clinical documents required for regulatory submissions to ensure rapid, accurate and timely submissions to health authorities.
- The CDM Technology Team Lead drives CDGM strategic initiatives related to implementation, operations and business administrative support for enterprise document management systems to manage Clinical Documents originating from Clinical Trials.
- **Your responsibilities**:
Your responsibilities include, but are not limited to:
- Act as key CDGM/TMF contact for Regulatory Affairs, Quality with the Porfolio Execution Organisation (PEO) to ensure CDGM service are aligned with regulatory and other stakeholder requirements in relation to completeness of TMF and management of Clinical Trial Documents.
- Lead and drive system strategy roadmap and efficient processes & integrations based on solid understanding of the Novartis enterprise systems landscape and as per compliance and business priorities.
- Partners effectively with cross-functional stakeholders (e.g., Regulatory Affairs, Quality) to ensure CDM systems are managed, updated and operated in agreed strategy and timelines to ensure seamless availability
- Lead and be active contributor and owner of activities related to Incident Management, Change Management and ongoing operations of the electronic Document Management System(s)
- Lead internal resource allocations and oversight for vendors delivering CDM Systems services.
- Lead a high performing Business Administration team supporting 24/7 operations to ensure continuous and timely availability of CDM content for global business users
- Leads the CDM Technology team - recruits, retains, manages and develops associates through coaching and feedback, talent reviews, and managing performance.
- Key member of cross-functional teams on business process, performance or system enhancement initiatives focused on Document Management systems used by Clinical and Regulatory Affairs teams, as required & support CDGM and business teams in preparation for and during audits & inspections.

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**

**What you’ll bring to the role**:

- Education: Bachelor’s degree in life science/healthcare or IT.
- Languages: Fluent English (oral and written).
- Extensive experience working in Pharmaceuticals, Lifesciences and Clinical Research with specific experience in managing clinical document management, TMF and/or records & information management with prior experience in Electronic Document Management systems, specifically in Clinical and Regulatory highly desired.
- Business relevant technical and working experience of eDMS systems like Veeva Clinical vault, RIM, Documentum D2LS or similar &n deep knowledge of industry wide Electronic and Clinical Document Management systems and features
- Functional knowledge of business process and workflows used for Clinical, TMF, Regulatory functions
- 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).

**You’ll receive**:
Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 25 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities.**Why consider Novartis?**
766 million. That’s how many lives our products touched in 2021. 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.

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