Job Id: 20201106009
Job Role: Clinical Data Manager
Experience: 3 Years
Qualification: University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.
Job Location: Hyderabad
Salary: Best in Industry
Vacancies: Not Mentioned
Job Description Novartis Careers Pharmacy / Life Sciences / Nursing for Clinical Data Manager in November 2020:
• 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
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.
• 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