Business Administrator

2 weeks ago

Hyderabad, Telangana, India Novartis Full time
Job Purpose

  • Responsible for timely and quality business support and system ownership of the electronic document management system(s) (eDMS), related compliance and efficiency of document management processes.
  • Act as Subject Matter Expert for process and related technical specification for electronic Document Management System(s):
  • Support development and implementation of Strategy roadmap for the eDMS systems as per compliance and business priorities.
  • Support implementation of efficient processes & integrations aligned with company enterprise systems landscape, partnering with business, internal and vendor stakeholders. on requirements gathering and translation into functional specifications to ensure efficient and compliant electronic document management/interface processes
  • Own and drive improvements and innovation projects on business and technical aspects, including feasibility assessments and implementation activities
  • Act as Business lead of IT projects and in this role coordinate and/or perform test case creation, informal/formal testing, SOP revisions, migration preparation (mapping, cleanup activities), design business support concept, coordinate and/or establish training material concept & creation, plan and conduct trainings and rollout activities as well as manage Extended Business Team and other local stakeholders.
  • Proactively share knowledge with other eDMS CoE team members. Coach and mentor, the new joiners to bring them up to speed and support team efficiency and cohesiveness
  • Maintain oversight of service quality of the Document Management system:
  • Act as System Owner of one or more electronic Document Management Systems
  • Business ownership of system releases coordinate with IT and other functions for cutover and rollout. Coordinate system maintenance activities and system upgrades in close collaboration with IT, Superusers and Key Business Functions.
  • Maintain oversight of service quality towards clinical document management business users
  • Oversee operational activities of a document management support team (e.g. external vendor BA team) ensuring that group meets targets/SLAs for efficiently maintaining the electronic clinical document management system through operational activities.
  • Monitor Business Administration performance and its impact on the business organization.
  • Engage and manage eDMS system superuser community.
  • Develop and recommend risk management, contingency plans and corrective or preventative actions to improve quality and compliance. Own CAPA's as needed to ensure delivery as per timelines.
Ensure quality, timeliness, and efficiency and high document standards for eDMS usage. Ensure deliverables comply with HA guidelines, Good Clinical Practices and Company SOP Represent eDMS CoE in inspections as needed, providing SME input and coordination of inspection requests (e.g.

, provision of audit trail data, coordination of inspector system access)
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

  • Bachelor's degree in life science/healthcare is required with minimum 6 years' experience in clinical operations, Regulatory Affairs and/or clinical systems management
  • Prior 2 years of Veeva eTMF Vault experience preferred
  • Experience in crossfunctional, multicultural and international clinical trial teams; able to work independently.
  • Good knowledge of clinical development process, regulatory requirements, GCP and Data Integrity requirements. Company experience in these areas is preferred.
  • Excellent understanding of system data structures and Clinical Document Management System functionality
  • Hands on Veeva Vault experience to perform eTMF Business Administration activities highly desired
  • Prior hand on experience working on and thorough understanding of Clinical document management systems like Documentum D2LS, Veeva
  • Proficient knowledge of CTMS, EDC, IRT systems
  • Ability to learn new systems readily
  • Strong computer skills MS Teams, (EXCEL, MS Word) required
  • Excellent attention to accuracy and details
  • Excellent communication, organization and tracking skills.
  • Strong operational skills and demonstrated ability to meet timelines.
Why Novartis?

766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation.

That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously ta

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