Senior Clinical Data Scientist

3 days ago

Dublin, Dublin City, Ireland Novartis Ireland Full time

Join to apply for the Senior Clinical Data Scientist role at Novartis Ireland

2 days ago Be among the first 25 applicants

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Summary
We are seeking multiple Senior Clinical Data Scientists responsible for providing timely & ongoing management of data management, coding, CDDRA-Database Development, DAP deliverables, and clinical trial data management, ensuring quality, cost efficiency, and adherence to timelines across trials. Responsibilities include developing training modules, leveraging technology for process improvements, and ensuring compliance with GCP and data handling standards.

Participants will review clinical research protocols, reports, and statistical analysis plans, contributing to data quality and process improvements within Data Operations. The role involves managing data loads, transfers, and ensuring data conforms to standards, supporting clinical trial teams, and leading data provisioning activities from phase I to IV in global drug development.

Major accountabilities:

  1. Provide data management leadership and act as Trial Data Manager as needed, understanding the compound profile to optimize data management processes.
  2. Ensure well-written protocols and amendments, resolve protocol issues impacting databases, and perform data handling activities including UAT and database setup.
  3. Maintain compliance with global regulatory requirements, ensure quality standards, and coordinate audits and inspections.
  4. Review data from clinical studies, generate status reports, support junior staff, and lead initiatives for quality and efficiency improvements.
  5. Serve as primary study lead, establishing strong relationships with study teams, acting as technical consultant, and leading data activities for clinical phases.
  6. Report technical issues related to products within 24 hours and manage sample distribution where applicable.

Minimum Requirements:

  • Degree or Master's in a relevant field.
  • At least 4 years' experience in Clinical Data Management within drug development.
  • Experience managing multiple end-to-end studies, strong organizational skills, and knowledge of clinical trial methodology, GCP, and medical terminology.
  • Ability to interrogate data using programming or GUI techniques.

Commitment to Diversity & Inclusion:
We are committed to building an inclusive work environment and diverse teams.

Why Novartis: We are dedicated to helping people through innovative science, collaboration, and a supportive community. Join us to create a brighter future: https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Sign up to stay connected and learn about new opportunities: https://talentnetwork.novartis.com/network

Benefits and Rewards: Learn more about our offerings: https://www.novartis.com/careers/benefits-rewards

Seniority level
  • Mid-Senior level
Employment type
  • Full-time
Job function
  • Research, Analyst, and Information Technology
Industries
  • Pharmaceutical Manufacturing

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