Location
Hyderabad | India
Job description
About the role
Clinical Data Scientist
Location – Hyderabad/ Mumbai
About the Role:
Provide timely and professional ongoing management of Data Management deliverables and of clinical trial data with respect to cost, quality and timelines for all assigned trials within Clinical Data Management. Ensure consistently high quality data available for analysis and reporting.
Key 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 performimg 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 abiity 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
Role Requirements
Essential Requirements:
• Education (minimum/desirable): University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.
Desirable Requirement:
• 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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Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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