817 million. That's how many lives our products touched in 2018. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
The Clinical Data Analyst ensures the successful end-to-end operation of clinical data transfer process. The role supports the optimal planning and execution of all activities associated with data transfers. This role serves as the data management expert on multidisciplinary clinical project teams providing specific expertise on timeline development and identification of data management deliverables.
Work with the project management, Laboratory staff and GxP Systems team on study start up activities, including data entry, database screen testing, edit/check software tool development and perform testing. Work in conjunction with study project managers and technical laboratory staff to understand data transfer specifications and study timelines to help assess and ensure that proposed solutions satisfies requirements, timelines, broader data management and BioPharma goals. Work with CDM, GxP systems and Project Management teams to facilitate agreements, maintain project timelines, drive project completion, escalate issues as appropriate and maintain study data transfer deadlines.
Communicates with Project Managers, MIRTH team, LIMS team and test method leads on a regular basis to meet data management deliverables on the multiple projects to ensure milestones meet timelines and quality deliverables. Communicate data issues and/or query trends to Sponsor and/or project team, as appropriate
Assess issues / generate solutions in data handling created by the changing requirements in clinical data processing.
Escalate any potential or actual issues to supervisor, project team, and/or Sponsor in a timely manner, and follow issues through to resolution
Ensuring that Quality Events such as incidents and deviations are proper documented, and for supporting/owning the immediate remediation and preventative actions and ensuring change requests are properly initiated, completed, and approved prior to the use of the assay, system, instrument, software, etc. being changed.
What you will bring to the role:
Master of Science with 1 year or Bachelor of Science with 2 years or minimum of 3 years direct Clinical Data Management or Laboratory Experience handling various types of data
Strong background in handling various types of laboratory generated data across various molecular and protein based platforms
Excellent verbal and written communications skills and ability to interact with personnel at all levels cross-functionally
Knowledge of GxP and experience in validation, data analyst configurations and data application.
Clinical research and clinical trial experience preferred
Why consider Novartis?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.
We are Novartis. Join us and help us reimagine medicine.