Senior Clinical Trial Data Manager

2 weeks ago

Bengaluru, Karnataka, India Novo Nordisk AS Full time
Department: Data Management & Centralised Data Review Are you prepared for a challenging role as a Senior Clinical Trial Data Manager? Do you possess expertise in clinical trial data management and a dedication to ensuring top-notch data delivery? Join our team in Bangalore, India, and have a positive impact on the healthcare sector. Keep reading and seize the opportunity for a rewarding career. The Role The Senior Clinical Trial Data Manager is tasked with a wide array of responsibilities to efficiently manage all global data management activities related to data review and proactively anticipate forthcoming challenges. Moreover, this role entails overseeing data review projects and ensuring seamless end-to-end trial data review delivery from data management (DM). As a Senior Clinical Trial Data Manager at Novo Nordisk, you will have the chance to:
  • Manage data review project activities and oversee the data review process for assigned clinical trials.
  • Ensure end-to-end data review delivery, meeting project goals and plans.
  • Lead the data review process in clinical trials, identifying and mitigating risks, enabling decision-making, and providing management reports.
  • Ensure availability of clinical data meeting regulatory and quality standards.
  • Implement data review tools and interfaces, establish & execute a data Monitoring Plan.
  • Conduct database lock activities for submission-ready data and handle any major issues.
  • Maintain clear communication with trial partners.
Qualifications To excel in this role, candidates should have the following qualifications:
  • MSc/BSc in Natural/Life Science or relevant field.
  • 4 - 6 years of data management expertise within the Pharma Industry or Development.
  • Solid knowledge of clinical systems and relational database systems.
  • Experience in data systems management, data analysis, data quality, and integrity assurance.
  • Proficient in data acquisition, transformation, harmonization, and regulatory submissions.
  • Familiarity with data management tools, trial regulations, and data governance.
  • Understanding of data architecture and business communication.
  • Knowledge of Good Clinical Practices (GCP) and/or Good Laboratory Practices (GLP).
  • Ability to review clinical research protocols, reports, and statistical analysis plans.
About the Department Our Clinical Data Operations & Insights team comprises around 400 professionals across India, Denmark, and North America. Data Management falls under Development, where we oversee global clinical drug development, ensuring adherence to global standards, regulations, and ethical practices while delivering impactful products for patients and society. The newly established Data Review and Cleaning unit is part of the Data Management & Centralised Data Review Department based in Bengaluru. This unit aims to centralize and modernize data review and cleaning processes, introduce new methodologies, and develop innovative toolkits for support. Working At Novo Nordisk Novo Nordisk is a prominent global healthcare company with a century-long history of combatting severe chronic diseases. Expanding beyond our strong diabetes legacy, we are reaching a larger audience worldwide and positively impacting over 40 million patient lives each day. These achievements have positioned us as one of the top 20 most valuable companies globally. Our success is driven by the collaboration of our 63,000+ employees worldwide. We value the unique skills and perspectives our employees offer and strive to cultivate their full potential.

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