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 management decisions and propose strategies at study or project level.
• Ensure application of consistent data management processes, influence increased standardization and documentation across assigned project/programs -Comply with company, department and industry standards and processes.
• Provide and implement data Management solutions; ensure knowledge sharing.
• Leads process and training deliverables within multiple platforms, franchises or therapeutic areas. Develops strategies to ensure effective training and knowledge retention.
• Progresses towards complete, compliant, agile and simple end to end processes and effective training (Protocol/Measure through Analysis and Reporting).
• Representative 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)

Minimum Requirements:

• Degree / Masters qualified in a relevant area
• Ideally 9+ years’ experience in Drug Development with at least 8 years' in Clinical Data Management
• Experience working across several end to end studies
• Strong leadership, collaboration and organizational skills with proven ability to successfully manage simultaneous trials and meet deadlines
• Excellent understanding of clinical trials methodology, GCP and medical terminology
• Proven ability to interrogate and view data through various programming/GUI techniques.