About the role
Responsibilities • Read and understand the protocol to be able to incorporate the data points into specification • Greater transparency with study team regarding timelines and impact of delays on overall eCRF development timelines • With the Data Managers, attend and contribute to the study discussions. • Lead and Conduct eCRF Design Meetings • Document decisions and issues by creating backlog ID in Project Binder during eCRF Design meetings • Develop eCRF screens as per the eCRF specification in Veeva Studio • Configure SDV/SDR, Safety and Coding within Veeva CDMS tool • To review the edit check specification document for clarity and to ensure checks are consistent and appropriate based on e-CRF design • Program new study specific checks, Protocol Deviation checks, Email Checks as per edit check specifications (Should be aware of tips and best practices of Veeva Rules) • Validate and Perform developer level testing • Provide the UAT details to Validation Team and Study Data Manager • Completion of all activities as detailed in the relevant section of the developer checklist. • Forwards the Go Live / Training e-mail details to the Study Data Lead(SDL) for inclusion in the Go-Live e-mail • Review and promote SDS, Annotated eCRF, TandE, Blank eCRF ..etc files in eTMF system • Confirms all required documents in eTMF system and Project Binder within Veeva Qualifications: BACHELOR OF ENGINEERING, BACHELOR OF PHARMACY, BACHELOR OF SCIENCE ( B.Sc Degree ), BACHELOR OF SCIENCE (B.Sc), M.SC.