Resumen
About the Role
Major accountabilities:
- Lead functional activities for a medium to large sized project in phase I to IV clinical studies in Novartis Global Development Organization.
- Co-ordinate activities of Data Managers either internally or externally.
- Make data Mgmt decisions and propose strategies at study or project level.
- Ensure application of consistent data Mgmt processes, influence increased standardization and documentation across assigned project/programs -Comply with company, department and industry standards and processes.
- Provide and implement data Mgmt solutions; ensure knowledge sharing.
- Leads process and training deliverables within multiple platforms, franchises or therapeutic areasDevelops strategies to ensure effective training and knowledge retention.
- Progresses DO towards complete, compliant, agile and simple end to end processes and effective training (Protocol/Measure through Analysis and Reporting).
- Drives towards agreed deliverables, proactively addressing potential issues before they become problematic -Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical data Mgmt aspects.
- Represents DO in all audits and inspections, centralizing and aligning the team in audit preparation, readiness and response.
- Act as subject matter expert (SME) or, as assigned, lead process improvement/non clinical project initiatives.
- Develops risk Mgmt strategies to prevent data quality/coding issues from derailing projects -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
Key performance indicators:
- Achieve high level of quality, timeliness, cost efficiency and customer satisfaction across Data Mgmt activities and deliverables.
- No critical audit findings due to Data Mgmt -Effectiveness of participation in internal and external networks/initiatives.
- Adherence to Novartis policy and guidelines -Customer / partner/ project feedback and satisfaction
Minimum Requirements:
Work Experience:
- Cross Cultural Experience.
- Functional Breadth.
- Project Management.
Skills:
- Clinical Data Management.
- Data Architecture.
- Data Governance.
- Data Integration.
- Data Management.
- Data Profiling.
- Data Quality.
- Data Science.
- Data Strategy.
- Master Data.
- Project Management.
Languages :
- English.
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