Job Opportunity :: eTMF Business Systems Analyst :: Basking Ridge, NJ

eTMF Business Systems Analyst

Location: Basking Ridge, NJ; onsite 1 time a quarter travel cannot be expensed

Duration: 7 months with ongoing extensions

Must Haves:

5 years of experience working as a Business Systems Analyst

Strong experience with Veeva eTMF (configuration, system changes, upgrades, etc.)

Experience gathering requirements, building business cases, supporting ongoing change controls and system updates

Experience with system ownership understanding requirements, changes, coordination with vendor on new releases

System compliance and UAT experience

Ability to assist with creation and maintenance of eTMF reports, dashboards, and end user reference materials; ability to analyze TMF metrics

Good communication

JOB DESCRIPTION

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.

Responsibilities:

1. Executes multiple, highly complex TMF-related processes for the oversight of documents flowing through the eTMF system. 25%

2. Manages the flow of support tickets for end-user access and document metadata correction. 20%

3. Executes processes for other relevant systems supported by Clinical Systems & Records. 20%

4. Manages centralized department and system-specific mailboxes and routes inquiries accordingly. 10%

5. Communicates and actively collaborates with managers and leaders concerning the TMF

processes, eTMF system, and support tickets. 15%

6. Attends and participates in department meetings and end-user forums to develop increased knowledge and application of system tools, to improve business processes 10%