Novartis is inviting applications from eligible and interested candidates for the post of Clinical Data Manager for its Hyderabad location.
About Novartis
Novartis AG is a Swiss-American multinational pharmaceutical corporation based in Basel, Switzerland, and Cambridge, Massachusetts, United States (global research). It is one of the largest pharmaceutical companies in the world.
Job Responsibilities
- 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
How to Apply?
Interested applicants can apply for the post through this link.
Job Location
Hyderabad
