Novo Nordisk Global Business Services (GBS) India
Department - Clinical Drug Development (CDD) - Bangalore Global Development
Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then we might have the right position as Statistical Monitor for you. Apply now and join a growing team, working in an international environment.
About the department
Clinical Data Science, Global Business Services (CDS GBS) was started in September 2007 and within a short span of 16 years since its inception, has transitioned from a small start-up to one of the largest units in GBS and a key contributor to Novo Nordisk clinical development portfolio. As the organisation is growing along with the Research & Development portfolio, we are looking for several new medical Reviewing colleagues. In Clinical Data Science, we are responsible for managing clinical drug development worldwide from early development phases to product introduction. The CMU Bangalore is established in GBS to support the Risk Based Monitoring of clinical trials conducted by Novo Nordisk in line with health authority requirements. The unit is responsible for performance of centralised medical review of patient data that includes medical monitoring and lab surveillance; Statistical Monitoring analysis, and generation of visualisations and reports identifying outliers and trends from various data sources.
The Position
The Statistical Monitor plays a critical role in supporting Risk-Based Monitoring within Clinical Drug Development by operating and maintaining the centralized Statistical Monitoring function. This position focuses on detecting unusual data patterns, systematic errors, and potential instances of non-compliance or fraud that may not be identified through routine monitoring processes. The Statistical Monitor analyses clinical data across trials and projects to safeguard data integrity, which is essential for the approval of new drug. The role requires a high level of independence, with the potential to mentor junior colleagues and contribute to continuous improvement in data reliability and compliance.
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