Qualifications - BACHELORS’ DEGREE IN A SCIENTIFIC / TECHNICAL DISCIPLINE IS
PREFERABLE
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 current 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
Location
Mumbai
Job Function
BUSINESS PROCESS SERVICES
Role
Executive Assistant
Job Id
422169
Desired Skills
Veeva vault
Desired Candidate Profile
Qualifications : BACHELOR OF PHARMACY, BACHELOR OF SCIENCE ( B.Sc Degree ), M.SC-TECH, M.SC.