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- Tasks: Lead innovative clinical document management systems and drive integration of AI/ML technologies.
- Company: Join Novartis, a diverse and inclusive employer committed to making a difference.
- Benefits: Enjoy flexible working, competitive salary, and opportunities for personal and professional growth.
- Other info: Hybrid role based in the UK with excellent career advancement opportunities.
- Why this job: Make a real impact in drug development while collaborating with passionate professionals.
- Qualifications: Advanced degree and significant experience in clinical research and document management required.
The predicted salary is between 80000 - 100000 £ per year.
This position plays a critical leadership role in a complex matrix with all parts of the R&D organisation that contribute essential records for drug development and implement strategies that incorporate many systems that hold clinical trial data. The Head, Clinical Document Management Integrated Systems drives initiatives in the Clinical Document Management tech space for example for: the implementation and embedding of regulatory, safety and site document exchange mechanisms in a sustainable way of working and integration of these capabilities into future clinical TMF strategies; the integration of existing systems and functionalities with future direction including AI/ML, genAI and automated workflows; support Non-Interventional study information management needs; incorporating clinical information from external sources contributing to the conduct of studies (e.g. CROs, BD&L inlicensed partners) including processes and automation, integration of these into the TMF strategies. You would also be responsible for designing and developing new business processes and strategies while proactively identifying business risks and proposing and implementing strategies to manage the implications of these risks on the business.
This position is a home worker / hybrid position based in the UK. Novartis can not offer relocation for this position. Please only apply if the country location suits you.
Key responsibilities but not limited to:
- Drive the implementation of the clinical records management systems innovation roadmap including ML/AI and relevant interfaces in partnership with GCO's Technology and AI, DDIT, QA and other relevant business functions
- Ensure efficient user support model for system related inquiries in a timely, efficient and resolutive manner
- Ensure effective business system ownership including maintenance of business rules, user requirements and metadata standards for digital data interoperability, transferability, reuse and preservation, and business administration (BA) activities
- Provide business leadership and support on GxP data/record migration and integration projects
- Foster thought leadership in the clinical operations tech space through proactive external network and industry associations (e.g. CDISC) contribution, keeping sight of evolving tech landscape; builds trusted relationships with internal Compliance and QA functions as well as Health Authorities inspectors
- Set, review and evaluate annual performance objectives for the team in alignment with company goals, establishes priorities and distribution of work, forecasts demand and resource needs and contributes to the CDGM budget cycles
- Recruit, retain, manage and develop associates through coaching and feedback, talent reviews and other available Novartis resources and tools
- Effective vendor management as demonstrated by SLA and KPIs vs budget and resources within 5% of cost overruns
- CDGM systems infrastructure compliant with Regulatory standards, GxP and expectations
- Significant contribution to building CDGM high performing team
- CDGM and travel budget accountability for own resources. Project and External budget accountability for provided services
Essential criteria:
- Advanced degree or combination of Bachelor's degree in information or life-sciences/healthcare and relevant industry experience.
- Significant years experience 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.
- Strong 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. CDISC 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 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.
- Good understanding of machine learning, automated workflows and artificial intelligence capabilities applied to records management is strongly desired.
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?
Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally.
Head, Clinical Document Management Integrated Systems employer: Novartis
Contact Detail:
Novartis Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Head, Clinical Document Management Integrated Systems
✨Tip Number 1
Network like a pro! Reach out to people in your industry, especially those connected to Novartis. Use platforms like LinkedIn to connect and engage with them. A friendly chat can sometimes lead to opportunities that aren’t even advertised!
✨Tip Number 2
Prepare for interviews by researching Novartis and their recent projects. Show them you’re not just another candidate; you’re genuinely interested in their work and how you can contribute. Tailor your answers to reflect their values and goals.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or use online resources. The more comfortable you are with your responses, the better you’ll perform when it counts. Focus on articulating your experience in clinical document management clearly.
✨Tip Number 4
Don’t forget to follow up after your interview! A simple thank-you email can leave a lasting impression. It shows your enthusiasm for the role and keeps you fresh in their minds as they make their decision.
We think you need these skills to ace Head, Clinical Document Management Integrated Systems
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your relevant experience in clinical document management and leadership. We want to see how your skills align with the role, so don’t hold back on showcasing your achievements!
Showcase Your Tech Savvy: Since this role involves integrating AI/ML and automated workflows, it’s crucial to demonstrate your understanding of these technologies. We’re keen to see how you’ve applied tech solutions in your previous roles, so share specific examples!
Be Clear and Concise: When writing your application, keep it straightforward and to the point. We appreciate clarity, so avoid jargon and ensure your key points stand out. This will help us quickly grasp your qualifications and fit for the role.
Apply Through Our Website: We encourage you to submit your application through our official website. It’s the best way for us to receive your details and ensures you’re considered for the position. Plus, it’s super easy to do!
How to prepare for a job interview at Novartis
✨Know Your Stuff
Make sure you have a solid understanding of clinical document management and the specific technologies mentioned in the job description, like AI/ML and automated workflows. Brush up on relevant regulations and standards such as ICH-E3 and CDISC TMF reference model to show you’re well-prepared.
✨Showcase Your Leadership Skills
Since this role involves significant leadership responsibilities, be ready to discuss your experience in managing teams and driving cross-functional projects. Prepare examples that highlight your ability to influence and motivate others, especially in a matrix environment.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving skills and how you handle challenges in clinical operations. Think of specific scenarios where you've successfully navigated complex issues or implemented innovative solutions, and be ready to share those stories.
✨Engage with the Interviewers
Don’t just wait for questions; engage with your interviewers by asking insightful questions about their current projects and future goals. This shows your genuine interest in the role and helps you gauge if the company culture aligns with your values.