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REGENXBIO · 3 months ago

Contract Clinical Systems Specialist

United States

Contract

Remote

Mid, Senior Level

$0/yr - $1/yr

5+ years exp

REGENXBIO is an exceptional place where some of the best and brightest people have the opportunity to collaborate on amazing science. As a Contract Clinical Systems Specialist, you will be responsible for clinical system maintenance and inspection readiness activities related to the Trial Master File (TMF) and Clinical Trial Management System (CTMS). You will work cross-functionally to support system setup, perform system quality checks, and manage inspection readiness issues.

BiopharmaBiotechnologyGeneticsTherapeutics

Responsibilities

Working cross-functionally to support system setup and customization as required

Performing eTMF inventory and document reviews per applicable study specific plans and procedures

Performing regular system quality checks and communicate compliance gaps to clinical trial team members, medical organization leadership, and any/all applicable stakeholders as needed

Working with Clinical System owners to manage inspection readiness issues to completion

Monitoring eCTMS completeness and accuracy and provide compliance status update to system managers/owners as needed

Supporting system data/document entry, including oversight of eTMF/eCTMS system directories (e.g. reference data repositories)

Monitoring system access and process user access requests

Participating in system related process improvement initiatives and standard document updates

Qualification

Clinical trial IT systemsICH/GCP principlesClinical research experienceETMF managementTeam collaboration

Required

Bachelor's degree with an emphasis on Life Sciences preferred

At least 5 year clinical research experience (or equivalent) handling/managing clinical system information (e.g. TMF documentation, eCTMS information, etc.)

Must have working knowledge of ICH/GCP principals and demonstrate a working knowledge of clinical trial execution

Must have experience with clinical trial IT systems such as electronic Trial Master File and/or electronic CTMS

Demonstrates familiarity with industry standards

Ability to work in a dynamic, fast paced, team environment