Senior Manager, Clinical Business Systems

The Opportunity:

The Senior Manager, Clinical Systems is a hands-on technical leader responsible for the daily administration, support, and ongoing enhancement of core clinical systems, including eTMF and CTMS, as well as the implementation and optimization of future platforms that support clinical operations (e.g., RBQM, Study Start-Up, IRT/RTSM).

This role will actively perform and oversee system configuration, user management, periodic reviews, and validation activities, ensuring systems remain compliant, reliable, and inspection ready. The individual will work closely with Clinical Operations, Data Management, Regulatory, CSV, Quality, and external vendors to support business needs while maintaining GxP compliance. Key responsibilities in this role include:

• Act as the hands-on system owner/lead for assigned clinical systems, supporting daily operations and issue resolution.

• Perform user lifecycle management activities including provisioning, modifications, deactivation, and role-based access control.

• Execute and document periodic user access reviews and audit trail reviews in alignment with SOPs and regulatory requirements.

• Perform system configuration updates, including role updates, metadata changes, and system enhancements.

• Support and participate in system implementations, upgrades, and integrations, including hands-on validation activities.

• Execute release management activities, including impact assessments, regression testing, and coordination of deployments.

• Manage and execute change control activities, including documentation, risk assessment, and approvals.

• Troubleshoot system issues, coordinate with vendors, and track resolution through ticketing systems (e.g., ServiceNow).

• Generate and review system reports to support compliance, audit readiness, and operational oversight.

• Ensure systems operate in compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+ data integrity principles.

• Support internal audits and health authority inspections by providing documentation, reports, and system walkthroughs.

• Partner with cross-functional teams to support end-user training, adoption, and process improvements.

Required Skills, Experience and Education:

• Bachelor's degree in information systems, Computer Science, Life Sciences, or related field.

• 5- 7 years of hands-on experience supporting clinical or GxP-regulated systems in a biotech or pharmaceutical environment.

• Veeva Vault administrator certification is strongly preferred.

• Strong experience with system administration, user access management, and periodic reviews.

• Hands-on experience supporting validated SaaS platforms and system implementations.

• Experience executing validation deliverables.

• Strong understanding of change control, release management, and system lifecycle processes.

• Working knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, and risk-based validation approaches.

• Ability to troubleshoot issues and translate business needs into system configurations.

• Strong documentation and communication skills.

Preferred Skills:

• Hands-on experience with Transperfect Trial Interactive eTMF and eClinical Elluminate platfoms

• Experience with audit trail review, role-based security models, and inspection readiness.

• Familiarity with identity and access management tools (e.g., Active Directory, Azure Entra).

• Experience with ServiceNow or similar ticketing systems.

• Exposure to clinical data standards and regulatory submission processes. 

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