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 acceptant test scripts. Escalates change control issues to system Business Owner as appropriate. Drive 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 eTMF system.

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

Responsibilities % of
Time ADA
E/N
1. Executes multiple, highly complex TMF related processes pertaining to the oversight of documents flowing through the eTMF system. 25
2. Manages flow of support tickets for end user access and document metadata correction. 20
3. Executes processes pertaining to 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

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .

To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .

Required Skills & Experience

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

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.