NOVARTIS
Clinical Data Manager Degree in life
science, computer science, Pharmacy, nursing or equivalent
Job
Description
500
studies across multiple therapeutic areas. This is the exposure and scale our
Data Management group has. We are on our journey to Reimagine medicine with
Data and Digital and our team is focused on delivering data which is fit for
purpose.
Innovation
at scale is one of the strategic pillars for us as a Clinical Data Management
team and you will have an opportunity to apply your skills to experiment and
innovate ways to transform the Clinical Data Management process in Drug
Development.
We
are looking for individuals with end to end experience in clinical data
management. You will play a key role in providing leadership to various teams
and developing cross-functional data cleaning strategies.
•
Provide professional DM input on Clinical Trial Team(s)
•
Input to and review of clinical trial database design including User Acceptance
Testing (UAT). Responsible for the Validation and Analysis Plan (VAP) meeting
for the clinical trial, which includes chairing the meeting, writing the study
specific validation checks and necessary reports to ensure high quality and
consistent data.
•
Identify errors and inconsistencies; resolve them or initiate their resolution
either via the field monitor or directly with the investigational site, to
ensure high quality and timely database locks.
•
Review and contribute to preparation of protocols, specifically related to the
data management section, visit schema and study design. Prepare Case Report
Forms (CRFs) and CRF completion Guidelines (CCGs), electronic or paper.
•
Support and provide leadership for data management staff for allocated trials.
•
Freeze and lock data as appropriate in time for statistical review, blinded
interim quality review, interim and final database lock.
•
Perform training on data management software and practices or trial specific
topics as required. Prepare training materials for data management activities
and processes as required.
•
Travel is required as needed.
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