Sr Manager, IT Clinical Systems Validation

Role Summary

Sr Manager, IT Clinical Systems Validation is responsible for validating and maintaining the validated state of the expanding technology landscape in support of clinical applications, ensuring regulatory compliance and data integrity. The role leads planning, execution, and documentation of computer system validation (CSV) activities and collaborates with business owners, QA, and CSV teams to meet GxP standards. It also involves vendor assessment, audits support, and project management across multiple clinical system implementations and upgrades.

Responsibilities

• Collaborate with business owners, QA, and CSV teams to ensure validation deliverables meet GxP and regulatory compliance standards.
• Author and/or review validation documentation including Admin SOPs, Risk Assessments, User Requirements (URS), and Test Protocols (IQ/OQ/PQ).
• Create change controls, periodic reviews, and revalidation activities throughout the system lifecycle.
• Evaluate and manage third-party vendors and SaaS/cloud-based clinical systems for data integrity and cybersecurity compliance.
• Drive continuous improvement of validation methodologies, templates, and SOPs.
• Support internal and external audits/inspections with documentation and demonstration of validation processes.
• Ensure system access, security, backup, and archival procedures meet regulatory and company policies.
• Provide project management support for clinical system implementations and upgrades, managing multiple projects and timelines.
• Monitor emerging regulations, technology trends, and industry best practices relevant to clinical systems validation.

Qualifications

• Required: Bachelor's degree in Computer Science or related field with 7+ years of IT/Clinical Systems Validation experience in Biotech/Pharma.
• Required: Strong understanding of GxP regulations, 21 CFR Part 11, Annex 11, and GAMP 5.
• Required: Hands-on experience with clinical systems validations.
• Required: Proven ability to manage multiple projects and priorities in a regulated environment.
• Required: Excellent communication, leadership, and stakeholder management skills.
• Preferred: Relevant certifications (e.g., GAMP, CSV-related trainings).
• Preferred: Experience in a biotech startup or high-growth clinical-stage company.
• Preferred: Familiarity with computer system assurance (CSA) principles.

Skills

• Regulatory compliance and data integrity
• Documentation and validation lifecycle management
• Vendor and SaaS/cloud system assessment
• Audit support and quality partnership
• Project coordination and stakeholder management

Education

• Bachelor's degree in Computer Science or related field

Additional Requirements

• Travel: Occasional travel approximately 10% (domestic/international/global)