eTMF Business Systems Analyst

The candidate will need to execute the strategy of TMF Operations as it pertains to the various systems supported. This role will be primarily focused on the eTMF system but will also assist with other system support. Assists in the requirements gathering, business case building, and support for ongoing change controls and system projects. Evaluates system change controls in sandbox environment to ensure they meet business requirements and expectations. Builds and/or executes user acceptance test scripts. Escalates change control issues to the system Business Owner as appropriate.

Drives the transfer and migration activities of studies and records into and out of the eTMF system. Assists in the creation and maintenance of eTMF reports, dashboards, end user reference material (Job Aids, QRCs, etc.) as required. Utilizes eTMF tools, dashboards, and technology to analyze TMF metrics and to communicate with study teams, peers, and system end users on actions required. Manage support tickets being routed for end user access and document metadata correction in the eTMF system.

Manage centralized mailbox flow for various systems supported by the Clinical Systems & Records department, ensuring inquiries are responded to and triaged promptly. Analyze and report metrics across other systems in the Clinical Systems & Records space as required. Able to accomplish tasks with a focus on data integrity/quality without supervision.