Full time ₹400,000 - ₹900,000 (INR) per year *
Description
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
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
