Dr. Reddys Laboratories is an emerging global pharmaceutical company with proven research capabilities. The company is vertically integrated with a presence across the pharmaceutical value chain. It produces finished dosage forms, active pharmaceutical ingredients and biotechnology products and markets them globally, with focus on India, US, Europe and Russia. The Company conducts research in the areas of cancer, diabetes, cardiovascular, inflammation and bacterial infection.
Post : Lead Clinical Data Management
Job Description
• Prepare and Review work instruction manuals and data base development guidelines
• Develop and review technical specifications for data management programming and database development schemes
• Direct and Confer with CRO’s to define, guide and ensure clinical database requirements such as data release formats, testing EDC systems, ensuring go live of database and timely project deliverables.
• Coordinate mock CRF design and review as per the standards and protocol.
• Develop and review project-specific data management like data coding, reporting, or transfer, database locks, and work flow processes.
• Managing build, test and validate electronic database systems.
• Perform edit check testing and user acceptance testing’s.
• Manage, review and resolve queries generated based on validation checks, query outputs and other problems identified during database development, production and closure
• Ensure, validate and execute regulatory compliant programs to perform clinical data management activities.
• Perform quality control checks to ensure accuracy, completeness and proper usage of data base systems and data.
• Prepare and review data reports, progress checks and status reports of clinical trial
• Review and manage medical data listings for completeness
• Organize and guide data clean meetings to ensure completeness of data
• Ensure and oversee overall data management related activities for smooth conduct of clinical trails
Additional Information
Qualification : M.Pharm
Location : Bachupally, Hyderabad, Telangana
Years of Exp : 8 to 15 Years
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th December, 2021
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