Associate Statistical Monitor

0 - 2 years

2 - 4 Lacs

Posted:2 hours ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Job description

Bangalore, India

Job category

Clinical Development

Novo Nordisk Global Business Services (GBS) India

Department: Centralised Monitoring Unit, CDS GBS - Bengaluru

Are you passionate about ensuring high-quality clinical trial dataDo you have a keen eye for detecting unusual data patterns and a drive to make a meaningful impact on clinical trial outcomesIf so, we invite you to join our team as an Associate Statistical Monitor in Bangalore. Read more and apply today!

The Position

As an Associate Statistical Monitor, you will play a key role in maintaining and operating the Statistical Monitoring function. Your responsibilities will include:

  • Operating and maintaining the Statistical Monitoring function to detect unusual data patterns, systematic errors, and potential non-compliance or fraud across trials and projects.
  • Collaborating with trial and project teams to plan and execute Statistical Monitoring activities.
  • Analyzing clinical trial data to identify irregularities and communicating findings to relevant stakeholders, including trial teams and management.
  • Contributing to the development of competencies in Statistical Monitoring by exploring new methods and tools and supporting training initiatives.
  • Sharing knowledge and insights to improve the quality of clinical trial data and prevent future occurrences of low-quality data.
  • Actively participating in meetings, training sessions, and continuous process improvement initiatives.

Qualifications

We are looking for a motivated individual with the following qualifications:

  • A university degree in life sciences or engineering (e.g., B.Sc., MSc, MD) or equivalent.
  • 0-2 years of experience in the pharmaceutical industry, preferably with exposure to clinical trial data exploration and visualization.
  • A solid understanding of clinical research, GCP, and data flow. - Basic knowledge of statistical methods and experience with reporting or publishing clinical/scientific data.
  • Proficiency in computer systems and IT, with exposure to SAS JMP programming.
  • Strong analytical skills, a quality mindset, and the ability to work independently with statistical monitoring and IT tools.
  • Experience working in a regulated industry and familiarity with GxP and drug development guidelines. - A team-oriented personality with cross-cultural awareness and flexibility. - A proactive approach to learning and adapting to new situations in a dynamic environment.

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Pharmaceutical Manufacturing

Bagsværd Kalundborg

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