Proven experience in clinical data management, data architecture, data governance, data integration, data profiling, data quality, data science, data strategy, and master data.
MBBS/M.D., Ph.D., or Pharm.D. required, with an M.D. highly preferred; subspecialty training and/or Real-World Evidence (RWE) experience is advantageous.
Contributes, with appropriate oversight, to all relevant aspects of global clinical trial activities to deliver study outcomes within schedule, budget, quality, compliance and performance standards. May lead specific aspects of global clinical trial. High quality contributions to study documents e.g. protocol, ICF, clinical sections of CTA -Clearly demonstrates Novartis Values and Behaviors i.e. Innovation, Quality, Collaboration, Performance, Courage and Integrity.
Has operational end to end responsibility for assigned supply activities. Leads and manages projects of different complexity and local network activities and participates in cross-functional teams.
Ensure completion of APQRs within defined timelines. Archival of the approved APQRs as applicable. Communicate with external suppliers to provide applicable approved supplier APQR and related documents to QOP.
Responsible for the drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs.
Qualification : M.Pharm, Age Limit Not more than 30 years as on 31 August 2026. Novartis funded research project. All-India Institute of Medical Sciences
Responsible for the drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs
Bachelors degree in a life science related field or a Registered Nursing certification or equivalent certification/licensure from an appropriately accredited institution.