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It Operations Lead Clinical Analytics
hace 3 meses
Location: Barcelona (Hybrid / Office) Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
We are seeking an IT Operations Lead to oversee and manage all day-to-day IT operations within our organization.
The ideal candidate will be responsible for ensuring seamless operations, managing licenses and vendor relations, supporting audit-related aspects, budget management, and ensuring compliance, quality, and security are maintained in all operational aspects.
About the Role Major accountabilities: Interact with various business stakeholders, 3rd party vendors, other IT line functions including Quality / eCompliance and information security.
Collection of operational demands/enhancement requests.
Overall process level understanding / identify process simplification opportunities and implementation.
Constantly update/review application roadmaps, technology modernization, elimination of unused assets.
Conduct service review meetings with business/vendors and ensure SLA/KPI adherence.
Ensure required training materials are up to date.
License management, budget management, contract management for various tools/vendors.
Escalation management.
Overall quality management, technical security management, User access management.
Audit readiness, support for both internal and external audits.
Ability to support critical / major incidents (major incident management).
Adherence to GxP compliance processes / requirements / documentation.
Management of Quality events, Risks, deviations, periodic reviews.
Keep abreast with internal IT systems and documentation requirements, standards (including quality management and IT security), regulatory environments / requirements (if applicable), DDIT Service Portfolio and with industry best practices.
Develop operational cost estimates and complete financial model (costs, savings, revenue opportunities, investment horizon, etc.).
Perform change impact assessment and formulate a right and compliant approach to development and deployment of changes.
Ensure implemented solutions are according to specifications and fit for purpose.
Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
A minimum of 10+ years of experience in working in the Pharma or IT Industry.
A minimum of 8+ years of experience in the Pharma domain.
A minimum of 6+ years of experience in a service operations role.
Expert understanding of business process analysis & design and system architecture concepts.
Expert understanding of the Clinical Trial Business processes, End to End drug development process experience an advantage.
Expert knowledge of GxP, 21CFR Part 11 and the CSV lifecycle.
Knowledge of Clinical Data Platforms, Statistical Computing Environments and Clinical Data Management is desirable.
Prior working experience in Clinical Analytics domain and knowledge on business processes is preferred.
Ability to solve complex business process / information challenges.
Proficient skills in global teams, collaboration, facilitation, negotiation, working in a matrix environment and conflict resolution.
Working knowledge of product management, agile methodologies an advantage.
Exposure/working experience in digital innovation projects/operations is an added advantage.
Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world.
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