Novo Nordisk Hiring 2022 B.Sc., MSc, MD for Associate statistical Monitor At Bangalore, India . Novo Nordisk Notification full details below..Interested and eligible candidates can Apply Now.
- Vacancy details:
- Post Name: Associate statistical Monitor
- Qualification: B.Sc., MSc, MD
- Experienced:0 to 2 years
- Openings:NA
- Salary: NA
Job Description: Novo Nordisk Hiring For Associate statistical Monitor !
- Important Details :
- Location: Bangalore, India
- Note:For further information, please contact Priyanka Ramaasokan at PYRS@novonordisk.com
- Post of date: 18/06/2022
- Selection Process: The selection will be on the basis of Interview.
Roles and Responsibilities
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.
Key Responsibilities/Main Job Tasks:
- 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.
Qualifications:
Education:
Holds University degree in life science or engineering (e.g. B.Sc., MSc, MD) or equivalent.
Experience:
- 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.
Personal Skills:
- Independent drive and ability to get tasks done within agreed deadlines
- Quality mind-set and strong analytical skills
- Preference for working independently with statistical monitoring and IT tools
- Team oriented personality with high degree of flexibility and cross-cultural awareness
- Good presentation, communication and collaboration skills
- Training and Mentoring of the new team members
- Ability and willingness to adjust quickly to new situations in a continuously developing environment
- Act as ambassador for NN Way.
About the Department
Clinical Data Science, Global Business Services (CDS GBS) was started in September 2007 and within a short span of eight 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 support 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; and generation of visualisations and reports identifying outliers and trends from various data sources.
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