Senior Manager, Clinical Business Systems

About Us:

Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.

Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company completed an initial public offering (IPO) in February 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location.

Position Summary:

The Senior Manager, Clinical Business Systems is responsible for the administration, support, governance, continuous improvement, and compliance of Structure Therapeutics' GxP-regulated applications. Reporting to the Associate Director, GxP Operations, this role is the primary operational owner and business partner for validated platforms supporting Clinical, Quality, Regulatory, and Technical Operations, including Veeva Vault QMS, QualityDocs, LMS, CTMS, and eTMF; Box; DocuSign; and other regulated systems. The role combines hands-on administration with process optimization, vendor management, and cross-functional collaboration to keep platforms scalable, inspection-ready, and aligned with evolving business needs.

Job Responsibilities:

GxP Application Administration & Support

Serve as the hands-on primary administrator for GxP applications including Veeva Vault QMS, RIM, LMS, CTMS, and eTMF; Box for Life Sciences; DocuSign Part 11; and other validated systems as applicable.

• Serve as product owner for assigned GxP applications, driving platform lifecycle management, continuous improvement, and adoption.
• Manage day-to-day system administration activities including user provisioning, role assignments, configuration updates, and system maintenance activities.
• Act as the primary point of contact for GxP application support requests and IT GxP-related service tickets, ensuring timely resolution and escalation when necessary.
• Coordinate system releases, upgrades, and configuration changes in partnership with vendors and internal stakeholders while ensuring compliance with change control procedures.
• Support system validation and maintain required documentation to ensure applications remain in a validated state.

• Partner with business stakeholders to prioritize enhancement requests, recommend process improvements, and maintain application roadmaps aligned with business priorities.

• Develop and maintain system documentation, knowledge articles, and administrator procedures.
• Support end-user training, adoption, and change management for new capabilities and releases.

• Perform audit trail reviews and user access reviews.
  
  

IT GxP Compliance & Operational Oversight

• Ensure validated systems remain inspection-ready through effective governance, risk-based Computer Software Assurance (CSA), and lifecycle management.
• Support regulatory inspections by providing system documentation, validation artifacts, audit evidence, and subject matter expertise.
• Conduct routine user access reviews and audit trail reviews and system compliance monitoring activities in accordance with approved procedures.
• Partner with Quality Assurance and Regulatory Affairs to ensure alignment of IT practices with GxP requirements, including data integrity (ALCOA+ principles), electronic records, and electronic signatures.
• Assist in the investigation, documentation, and remediation of GxP system deviations, incidents, and CAPAs.
• Initiate required Change Controls and monitor progress.
• Conduct gap analyses for new and existing (legacy) systems and develop remediation plans to address compliance findings and support the company’s Inspection Readiness Program.
• Support internal audits and manage CAPAs related to IT GxP findings, driving root cause analysis and timely remediation.
  

Vendor Oversight

• Manage day-to-day relationships with managed service providers (MSPs) and GxP application vendors.

• Monitor vendor performance against service l