Accountability Supporting Activities
•Utilize current study documentation including the Protocol, Independent Reviewer Charter (Assessment criteria) / Reviewer Manual, eCRF, QC guidelines etc.
•Maintain all supporting documentation for studies in accordance with SOPs/Guidelines/Work Instructions to ensure traceability and regulatory
compliance. This includes the documentation of any deviations and dissemination of these to the rest of the project teams.
•Maintain Study level technical documentation.
•Build and execute project specific requirements at study level in standard format.
•Maintain consistency in programming by understanding standard regulatory requirements.
•Accountable for first time quality on all deliverables
•Assist in providing technical and domain level solutions to internal or external sponsor queries.
•Develop wider knowledge in Imaging Systems and reporting along with other programming language usage and process within PSG.
•Ensure adherence to SLA with respect to turnaround time once specifications are finalized.QualificationsWorking experience in ASP.NET MVC, jQuery, HTML, CSS and web development.
Understanding of relational database concepts.
Hands on Experience in SQL within Oracle
Must be very organized and have ability to multi-task.
Experience working within a formal SDLC is preferred
FDA 21 CFR Part 11 knowledge is preferred