Tools Required
- Rave
- Oracle Inform
- Veeva Studio
Roles and Responsibilities
Protocol reading and understandingDesign the eCRF layout and the database corresponding to the eCRFs to hold the data from the EDC systemSetup Core ConfigurationsImplementing the Dynamic rules as per the Sponsor requirementsExperienced in writing the Data Validation Specification (DVS)Create, test, and maintain trial-specific plausibility and consistency Edit Checks as per Data Validation SpecificationAnalyze complex checks and Develop Custom Functions using C# for Rave studies or other EDCExpertise in performing Technical and Functional ReviewIncorporate internal feedback and update programs as requiredMust Have
Scientific background : A solid understanding of Clinical Protocol, medical and scientific principles of conducting clinical trialsStrong writing and communication skills : The ability to clearly articulate and concisely explain complex informationResearch and analytical skills : Ability to gather, interpret, and synthesize data into insightful informationAttention to detail : Ensuring accuracy and adherence to guidelines such as Protocol, Specification, Library Standards, ICH GCP, etcProject management skills : Managing the document development process and meeting timelinesPeople management skills : Managing the team of highly qualified individuals (applicable for Team Lead role only)Location
Gurgaon / PuneEducational Qualifications
B.E. / B.Tech – Computer Science-based courses or Circuit BranchesM.Sc. / MCA – in the stream of Computer ScienceB.Sc. / BCA – in the stream of Computer ScienceSkills Required
Rave, Oracle Inform, Veeva Studio, eCRF Design, EDC Systems, Core Configuration Setup