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, TrialInteractive, 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 with 21 CFR Part 11, EU Annex 11 and ICH E6(R3) requirements for controlled access to computerized systems used in clinical studies.
- Retain (never delete) inactivated accounts so that the audit trail remains reconstructable.
- Provide records, metadata and audit trail extracts to support audit trail review, TMF oversight, audits and regulatory inspections.
- Support Software Development Life Cycle and validation activities for clinical systems under 18.1-NDIR, including user acceptance testing, installation qualification support, traceability and periodic review deliverables.
- Escalate system incidents, access concerns, data integrity issues and validation deviations to the system owner, business process owner and Clinical Quality Assurance as applicable.
Training and User Support- Act as first-line technical contact for clinical system end users; triage and resolve incidents or route them to the vendor or IT.
- Maintain system administration work instructions, job aids and configuration documentation.
- Support role-based training content and reference materials for system users.
Requirements:Education- Bachelor's degree in life sciences, information systems, computer science or a related discipline required; equivalent combination of education and directly relevant experience may be accepted.
Experience- Minimum 3 years' experience administering or configuring GxP computerized systems; clinical systems (eTMF, CTMS, EDC or equivalent) strongly preferred.
- Demonstrated experience with Veeva Vault administration (security profiles, permission sets, lifecycles, object configuration, Vault Loader, dashboards and reports) preferred.
- Experience supporting audits and regulatory inspections, including provision of audit trail and access records.
Knowledge and Training- Working knowledge of 21 CFR Part 11, EU Annex 11, ICH E6(R3) Good Clinical Practice and data integrity / ALCOA+ principles.
- Working knowledge of the TMF Reference Model and trial master file completeness, quality and timeliness expectations.
- Working knowledge of computerized system validation and Software Development Life Cycle requirements (18.1-NDIR), change control and periodic review.
- On-the-job training on CLN-023 (Trial Master File), CLN-023-WI-02 (Veeva Vault eTMF Management), CLN-039 (Clinical System User Access Management), CLN-040 and CLN-040-WI-01 (Veeva CTMS), plus required onboarding, IT security and compliance curricula, to be completed and documented prior to independent performance of the role.
Competencies- Strong problem solving, troubleshooting and analytical skills; able to translate business requirements into system configuration.
- Precise documentation discipline and attention to detail in a controlled, regulated environment.
- Effective written and verbal communication with technical and non-technical stakeholders across geographies and time zones.
- Ability to work independently, manage competing study timelines, and make risk-based decisions without undue operational pressure.
- Integrity and ownership; escalates rather than works around controls.
This position may be available in the following location(s): US - Remote
For U.S. locations that require disclosure of compensation, the starting pay for this role is between $85,000.00 and $115,000.00. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors.
U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.
