Senior Clinical Systems Administrator

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the worldfrom the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe.

We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.

** Objectives:*
* To provide technical administration of Bausch + Lomb clinical systems (including Veeva Vault eTMF, Veeva Vault CTMS, Zelta EDC, AI platforms) so that each system remains configured for its intended use, maintained in a validated state, and controlled in accordance with 21 CFR Part 11, EU Annex 11 and ICH E6(R3). The role provisions and reviews role-based user access, configures and supports study setup, troubleshoots system issues, maintains configuration and access documentation, and supports audit and inspection readiness for clinical study records.

** Responsibilities:*
* ** System Administration and Configuration*
* + Configure and maintain the Bausch + Lomb clinical system environments (including but not limited to Veeva Vault, Trial Interactive, Zelta, AI platforms, etc.) in accordance with approved change control, keeping each system in a validated state.

+ Support study setup and deployment.

+ Document configuration in the System Configuration Manual, or equivalent approved configuration record, and maintain its change log as needs change.

+ Verify that standard dashboards and reports are applied and configure study-specific views on request.

+ Troubleshoot system issues, inactivate erroneous records, and coordinate system updates, releases and vendor-delivered upgrades with IT and the business owner.

+ Support Vault Loader bulk create, update, upsert and delete operations, including data loading and reconciliation.

+ For outsourced (CTMS Transfer) studies: establish and activate the Vault-to-Vault connection, configure required fields and Outbound Clinical Mappings, coordinate CTMS Transfer Agreement approval, and monitor daily transfer activity and CDX issues.

** User Access Management*
* + Create, modify and inactivate user accounts on receipt of approved access requests, maintaining role-based provisioning consistent with the applicable User Role Matrix (CLN-039).

+ Assign security profiles and permission sets appropriate to each user's assigned responsibilities, including blinded and unblinded access segregation.

+ Observe segregation of duties: do not request, approve and provision access to the same user account.

+ Confirm required training is completed and documented before access is granted.

+ Perform and document periodic access reviews in coordination with the responsible business owner, and process inactivations following terminating events, role changes or study completion.

+ Apply time-limited, read-only audit and inspection access on notification of an audit or regulatory inspection, and remove temporary access at the conclusion of the activity.

Compliance, Data Integrity and Inspection Support

+ Maintain system access controls and audit trails in alignment…