Clinical Database Programmer

Tools Required

• Rave
• Oracle Inform
• Veeva Studio

Roles and Responsibilities

• Protocol reading and understanding
• Design the eCRF layout and the database corresponding to the eCRFs to hold the data from the EDC system
• Setup Core Configurations
• Implementing the Dynamic rules as per the Sponsor requirements
• Experienced in writing the Data Validation Specification (DVS)
• Create, test, and maintain trial-specific plausibility and consistency Edit Checks as per Data Validation Specification
• Analyze complex checks and Develop Custom Functions using C# for Rave studies or other EDC
• Expertise in performing Technical and Functional Review
• Incorporate internal feedback and update programs as required

Must Have

• Scientific background: A solid understanding of Clinical Protocol, medical and scientific principles of conducting clinical trials
• Strong writing and communication skills: The ability to clearly articulate and concisely explain complex information
• Research and analytical skills: Ability to gather, interpret, and synthesize data into insightful information
• Attention to detail: Ensuring accuracy and adherence to guidelines such as Protocol, Specification, Library Standards, ICH GCP, etc
• Project management skills: Managing the document development process and meeting timelines
• People management skills: Managing the team of highly qualified individuals (applicable for Team Lead role only)

Location

• Gurgaon / Pune

Educational Qualifications

• B.E. / B.Tech – Computer Science-based courses or Circuit Branches
• M.Sc. / MCA – in the stream of Computer Science
• B.Sc. / BCA – in the stream of Computer Science