-Shristi Sharma, Team bioXone
MSc Life Science candidates apply online for a Clinical Data Manager position that is available at Novartis. Novartis is hiring MSC candidates, as per the details below in their Research & Development area:
Job Title: Clinical Data Manager
Job ID: 303627BR
Division: Global Drug Development
Business Unit: GDO GDD
Employment Type: Regular
Your key responsibilities:
We are looking for individuals with end to end experience in clinical data management. You will certainly play a key role in providing leadership to numerous teams and developing cross-functional data cleaning strategies.
- Clinical Data Manager (CDM) provides data management input on Clinical Trial teams. Might have the role of TDM on small low complexity trials. Performs DM activities for the start-up of a study including preparing the eCRF, CCG’s where needed, Data Handling plan (DHP) Data Review Plan (DRP) as well as performing user acceptance testing (UAT) as applicable.
- Handle local laboratory 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 also starts to gather an understanding of new technologies that may be made use of in the course of clinical trials
- Performs ongoing review of all data generated from the clinical study including Third-party and also local lab data along with SAE reconciliation where applicable
- Guarantees activities that are performed are done with quality and also understanding of the procedure. Verifies and also tracks eCRF completion consisting of Inquiry resolution and provides data status updates as needed
- With support from the Trial Data Manager develops proposals to resolve issues that might occur during the running of assigned trials. With support from the Trial Data Manager gives input into Study Specification worksheets should assign trials to need to be outsourced
- Has a working knowledge of FDA and also ICH guidelines. Has proven capability to make use of the tools available to generate listings for data review and also where necessary provides these to the study teams. Generates the study status reports for use at Clinical trial team meetings
Minimum requirements:
What you’ll bring to the role:
- University or college degree in life science or equal relevant degree.
- Fluent English (oral as well as written).
- Solid technological abilities,
- Fluent English verbal and also written
- Preferably 3 years experience in Drug Development with at least 2 years in Clinical Data Management
Read about more jobs and vacancies on bioxone.in
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