eData Manager, Translational Sciences
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us one of the most rewarding employers in our field.
As eData Manager you will provide leadership in utilizing state-of-the-art technologies in information and content management and applying them to Translational Sciences (TS) edata management issues.
You will lead electronic data management initiatives and develop strategies for the management of electronic assets to meet business, legal and regulatory requirements. You ensure the effective, acquisition, description, preservation, future migration, access to and security of electronically recorded intellectual assets of TS. You have close alignment and collaboration with NIBR and other edata management activities and initiatives across Novartis.
- Drive strategy for capture and appraisal of digitally born material being created or acquired by TS
- Lead implementation of business processes for management of electronic objects from acquisition or creation to storage, access and disposition
- Provide assistance, advice and training for TS associates on procedures for acquisition, preservation and management of electronic materials
- Ensure development of guidelines for associates working with CRO’s and Strategic Partners for digitally born material to facilitate best practise management and acquisition of this material
- Develop and lead best practice and standards for ongoing storage, preservation and management of digital objects
- Lead research focused on particular formats and applications for eArchiving
- Support computer system validation (CSV) activities across TS
- Engage effectively with TS associates to ensure customer needs are understood and met
- TS representative for cross-NIBR activities for eData management
- Maintain expert knowledge on regulatory and legal requirements for edata/erecord management and industry best practice
Minimum Requirements
EDUCATION
University / advanced degree in Computing / Information Science
EXPERIENCE
- Good experience in a similar professional edata management / CSV position, preferably within the Pharmaceutical Industry, with a track record of project success/accomplishments
- Strong knowledge of edata management and computer system validation principles and practices
- Demonstrated knowledge of eArchive systems and automation techniques
- Good knowledge of computer system validation
- Familiarity with search engine strategies, technology and ediscovery techniques
- Proven leadership and process improvement start-up and implementation
- Excellent written and verbal English communication skills with successful presentation experience
- Excellent team work in a multidisciplinary environment
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