Job Description

Job description 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 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 Associate Statistical Monitor is responsible for operating and maintaining the centralised Statistical Monitoring function in Global Development. The Statistical Monitoring function is one element of the Novo Nordisk compliance with Risk Based Monitoring. The Statistical Monitoring function is responsible for identifying clinical data patterns which could indicate irregularities, non-compliance with protocol specifications, or fraud not otherwise captured. Findings which may impact the data quality of the registration package for a new drug application and thus the approvability of new drug candidates. The Associate Statistical Monitor is responsible for communicating irregularities to relevant stakeholders including management. Responsible for operating and maintaining the Statistical Monitoring function for the detection of unusual data patterns, systematic errors and potential lack of compliance or fraud across trials and projects in Global Development. Responsible for communicating findings to trial teams/project teams and management and contribute to the prevention of the occurrence of low quality or erroneous data and the correction of such data. Contribute in developing the competencies of structured Statistical Monitoring. Responsible for knowledge sharing, skill building and good collaboration with stakeholders and colleagues. Responsible for utilizing understanding of the trials data flow to ensure holistic analysis of data. Qualifications: Holds University degree in life science or engineering (e.g. B.Sc., MSc, MD) or equivalent. 0-2 years of experience in pharmaceutical industry and preferably 1 year of experience with exploration and/ or visualisation of clinical trial data and scientific data. Experience from clinical development and understanding of data flow. Thorough understanding of clinical research and GCP. Understanding of basic statistical methods, preferably experience from reporting/publishing clinical/scientific data. Good knowledge on computer systems and IT. Exposure with SAS JMP programming. Worked according to GxP and guidelines within drug development. Working at Novo Nordisk We are a proud life-science company, and life is our reason to exist. We\'re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things - from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we\'re all here - to ensure that people can lead a life independent of chronic disease. Contact To submit your application, please upload your CV and motivational letter online (click on Apply and follow the instructions). Apply Now! Deadline 28th, July 2023 We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we\'re life changing.

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