Clinical Document Management Specialist
7 days ago
At Novartis, we're committed to delivering exceptional results and fostering a culture of innovation. As a Clinical Document Management Specialist, you'll play a critical role in shaping our clinical document management systems, processes, and standards.
Job Summary:We're seeking an experienced professional with expertise in clinical documentation practices and processes to join our team. This is a unique opportunity to work with a global, cross-functional organization and contribute to the development and implementation of cutting-edge clinical document management strategies.
Key Responsibilities:- Lead the implementation of CDGM initiatives, projects, and process improvement activities to enhance clinical document management systems, processes, and standards
- Drive efficient and effective management, coordination, and oversight of CSR appendices for assigned studies to meet electronic publishing requirements, Health Authority guidelines, Good Clinical Practices, and Novartis SOPs
- Support the development and maintenance of submission readiness processes, contributing to or driving initiatives to improve and innovate business and technical aspects of submission readiness activities
- Serve as Subject Matter Expert on CSR appendices training materials, formal and informal processes, and tracking tools for CSR appendices oversight activities
- Bachelor's degree in life-sciences/healthcare/pharmacy/information management and relevant industry experience
- Thorough knowledge of clinical document management processes and advanced knowledge of clinical documentation practice guidelines & principles (Good Documentation Practice, Data integrity, ICH eCTD, and FDA Portable Document formatting specifications guidance)
- Experience of authoring, compilation, and formatting of CSR appendices according to ICH E3 and 5 years in clinical development/clinical operations or similar business area
- 2-3 years working experience with document management systems and excellent understanding of system structures and generic document management functionality
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. We offer competitive salaries and benefits packages, including health insurance, retirement plans, and paid time off. Our employees enjoy opportunities for growth and development, access to innovative products and services, and a dynamic work environment that fosters collaboration and creativity.
Estimated salary: £60,000 - £80,000 per annum
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