Principal Clinical Data Scientist

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