Reports to Global Study Leader of Data Management or Technical Global Team Leader for US and UK associates.
India associates report to the Clinical Data Programming Manager.
Performs as Technical Liaison with DPO Infrastructure group.
Trains and mentors all new starters eCRF Developers, Data Managers, and Infrastructure support on Inform and Central Designer SOPs and WIs.
Provides ongoing mentoring to eCRF Developers
Subject matter expert on Inform and Central Designer responsible for mentoring Data Management functions on technical issues.
Builds study eCRFs including screens and validation rules using standards library and creating study specific screens and rules as required per protocol.
Monitors and adheres to study timeline as it relates to assigned activities.
Attends SVWT meeting and contributes to study setup timings as agreed upon by the clinical study sub-team (CSST).
Participates in screen reviewing meetings with CSST
Provides technical expertise for study build giving feedback and advice on screen design to CSST.
Reviews and approves screens.
Generates Annotated eCRF for review and approval.
Create DVS and UAT test scripts in conjunction with Data Manager.
Reviews and approves DVS test data scenarios and UAT test scripts.
Reviews, resolves, and documents issues entered on eCRF Development Issue Log.
Performs unit testing of screens and DVS programs..
Perform deployment of trials in the external environment.
Performs peer and technical quality review of initial trials builds to ensure quality and adherence to standards.
Processes requests for UMT and peer review UMT setup.
Deploys cognos reports for InForm trials.
Assesses constructs and deploys post go live changes.
Assists in creating, testing and validation of tools and utilities to support DPO.
Attends Data and Programming Operations, CSST, and other meetings as needed.
Works with Infrastructure group on eCRF improvements and library support