Job Description
This job is with Autolus Therapeutics, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
Role Summary
We are seeking a highly skilled and organized Clinical Systems Specialist to support the management and functionality of clinical systems and processes. The ideal candidate will be responsible for ensuring the smooth management of user access, performing system validation, and collaborating with cross-functional teams for system updates, releases, and configuration changes. This role will support the review of release notes, contribute to UAT processes and manage system configurations and updates related to clinical studies.
Key Responsibilities
User Management & Access Control:
* Create and manage User Management Forms for system users.
* Oversee the granting and revocation of user access rights, ensuring compliance with organizational protocols and security standards.
* Run monthly user rights reports and handle any accounts new or to be disabled.
* Ensure that user roles and permissions are correctly assigned across systems and modules.
System Validation:
* Support the review of Release Notes for system changes, including assessing impact and ensuring proper implementation across relevant systems and modules.
* Support the User Acceptance Testing (UAT) and document creation collaborating with the IT and CSV team.
* Support the end user training.
* Support on the implementation of any new modules, systems and configurations on current systems.
* Perform system validation tasks to ensure that clinical systems operate according to specified requirements and regulatory guidelines.
* Collaborate with the IT and CSV teams to support User Acceptance Testing (UAT), ensuring that changes meet functional and technical requirements.
Study and Site Management:
* Add new clinical study, country, sites, Principal Investigators (PIs), Sub-Investigators (Sub Is), participants, vendors into the clinical system as necessary.
* Update and maintain accurate CSV entries to reflect the most current information.
* Create, review, and maintain templates and wizard configurations in the clinical system to ensure accuracy and compliance with study protocols.
* Provide ongoing support for system changes and upgrades, working with teams to ensure system functionality aligns with operational needs.
* Provide support to study teams for document uploads and QC, as required
#LI-DNI