Novartis Hiring Clinical Data Manager Degree in life science, computer science, Pharmacy, Nursing Apply Now
As Clinical Data Manager (CDM) provide data management input
on Clinical Trial teams. May have the role of TDM on small low complexity
trials . Performs DM activities for start up of a study including preparing the
eCRF, CCG’s where needed, Data Handling plan (DHP) Data Review Plan (DRP) and
performing user acceptance testing (UAT) as applicable
• Manage local lab set up for the Clinical Database as
applicable
• Under supervision ensures consistency of assigned trials
with program level standards
• Understands third party data requirements and begins to
gather an understanding of new technologies that may be used in the course of
clinical trials
• Performs ongoing review of all data generated from the
clinical study including Third party and local lab data as well as SAE
reconciliation where applicable
• Ensures activities that are performed are done with quality
and understanding of the process. Verifies and tracks eCRF completion including
Query resolution and provides data status updates as needed
• With support from the Trial Data Manager develops proposals
to resolve issues that may occur during the running of assigned trials. With
support from the Trial Data Manager gives input into Study Specification
worksheets should assigned trials need to be outsourced
• Has a working knowledge of FDA and ICH guidelines. Has
proven ability to use the tools available to generate listings for data review
and where necessary provides these to the study teams. Generates the study
status reports for use at Clinical trial team meetings
Minimum requirements
• University or college degree in life science, computer
science, pharmacy, nursing or equivalent relevant degree.
• Fluent English (oral and written).
• Strong technical skills,
• Fluent English verbal and written
• Ideally 3 years experience in Drug Development with at
least 2 years in Clinical Data Management
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