Senior Manager, Clinical Systems Quality Lead

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Overview

The Senior Manager, Clinical Systems Quality Lead, is responsible for developing and implementing the process and framework for the assessment and management of GCP technologies across Alnylam Clinical programs, including development, validation, implementation, and oversight. The incumbent will establish and operationalize expectations for technology selection, study specific user requirements and testing approaches, documentation standards and oversight responsibilities.

This role will collaborate across the Development and QA organizations to establish a risk-proportionate, quality-driven oversight to enable data integrity and regulatory compliance. The framework and processes will provide a sustainable foundation for compliance across studies, systems, devices, and vendors.

This position requires close collaboration with Global Quality Assurance (GQA), Clinical Development, and IT to ensure the suitability, integrity, and compliance of both vendor-hosted and internal technologies that support trial conduct and data collection.

Key Responsibilities

• Collaborate with Vendor Management, Clinical Operations and QA to proactively identify systems and technologies proposed for use in clinical trials.
• Drive a risk assessment process assessing factors such as GxP relevance, validation approach (internal or external) and supporting evidence, system criticality to study outcomes, and the complexity of study-specific functionality (e.g., calculations, data transfers, quality control checkpoints, and integrations).
• Create a sponsor oversight framework that defines responsibilities, expectations, and documentation standards across the system lifecycle from technology selection, vendor and study specific implementation requirements, vendor validation and sponsor supplemental validation, implementation, change control, decommissioning and archiving.

2. Oversight of Study-Level Technology

• Partner with GCP QA and study teams to ensure endpoint data flows capture all Technology steps and interactions, including, data entry, validation, transfers/system interfaces, data integrations, Quality Control/Quality Gateways, notifications, transformation, and data analysis to inform technology risk assessment.
• Lead or facilitate study-specific risk assessments for technology applications used in randomization, data capture, data monitoring, and analysis (e.g., EDC, eCOA, ePRO, EAS, IRT, eTMF, LIMS, safety databases).
• Align system assessment outcomes with study-specific database build requirements, specifications, validation and UAT documentation, and audit trail review expectations.
• Translate risk assessment outcomes into oversight expectations, including qualification needs, testing rigor & ongoing monitoring requirements and ensuring outcomes are reflected in supplier risk assessments and study Risk Management Plans.
• Conduct reviews to evaluate system functionality, technical controls, validation documentation, and data flow risks for study-specific configurations.
• Identify, communicate and coordinate with Quality Technology and Analytics team for the review of external validation processes and validation packages or the need for internal validation.
• Develop mitigation strategies to address identified gaps, including procedural updates, system controls, or vendor corrective and preventive actions.
• Ensure traceability between study-specific data flow, vendor system controls, and sponsor oversight activities.
• Support inspection readiness by ensuring clear documentation of sponsor responsibility and oversight rationale for computerized systems.
• Contribute to CAPA development and effectiveness reviews where study configuration or system-related deficiencies are identified in oversight activities, audits or inspections.
• Develop and deliver training materials and guidance documents for functional teams on risk assessment and associated oversight of vendor-managed systems supporting clinical trials.
• Monitor evolving regulatory expectations (FDA, EMA, MHRA, PMDA) and update internal frameworks to maintain compliance.
• Identify and contribute to process improvement opportunities to enhance efficiency, consistency, and traceability of system oversight.

Qualifications

• Bachelor's or Master's degree in life sciences, computer science, or a related discipline.
• Minimum 6-8 years of experience in clinical quality, compliance, data management, or computer system validation within the pharmaceutical, biotech, or CRO industry.
• Deep understanding of ICH E6(R3), EMA Guideline on Computerised Systems (2023), 21 CFR Part 11, CSV documentation standards, GAMP 5 and data integrity principles.
• Experience with e-systems in clinical trials, AI technology, cloud-based platforms, and data privacy considerations under GDPR.
• Experience leading risk assessments for computerized…