Senior Manager, Clinical Business Systems

Structure Therapeutics•South San Francisco, CA

7d•Hybrid

About The Position

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. 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.

Requirements

Bachelor's degree in Computer Science, Computer Engineering, Information Technology, Life Sciences, or a related field recommended.
8+ years of experience supporting GxP-regulated systems within the pharmaceutical, biotechnology, or medical device industries.
Hands-on experience administering GxP platforms such as Veeva Vault, Box for Life Sciences, DocuSign, SAS, and other regulated SaaS applications.
Deep working knowledge of global regulatory requirements for computerized systems including 21 CFR Part 11, EU Annex 11, GAMP 5, ICH guidelines, data integrity (ALCOA+), and FDA’s CSA guidance.
Experience supporting computer system validation (CSV) and/or Computer Software Assurance (CSA) activities for regulated systems.
Experience managing IT service tickets, vendor relationships, and managed service providers.
Strong documentation, organizational, and problem-solving skills.
Excellent communication and stakeholder management skills with the ability to work effectively across Quality, Clinical, Regulatory, and IT organizations.
Experience leading cross-functional technology initiatives and translating business requirements into scalable system solutions.
Demonstrated ability to influence stakeholders across Clinical, Quality, Regulatory, and IT organizations.
Ability to operate independently in a fast-paced environment while managing multiple priorities.

Nice To Haves

Veeva Vault Administrator certification preferred.
Experience with Veeva QMS, Veeva RIM, eTMF, CTMS, or similar enterprise GxP platforms.
Experience with clinical technologies such as CTMS, eTMF, RBQM, Study Start-Up, RTSM/IRT, or related platforms.
Experience with Clinical, Quality, and Regulatory business processes in a biotechnology or pharmaceutical environment.
Experience supporting regulatory inspections and internal audits.
Knowledge of Agile, Product Ownership, or ITIL service management practices.
Experience working within a clinical-stage biotechnology company.

Responsibilities

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.
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.
Manage day-to-day relationships with managed service providers (MSPs) and GxP application vendors.
Monitor vendor performance against service level agreements (SLAs) and operational metrics.
Conduct periodic operational reviews with vendors to assess service quality, enhancement planning, and continuous improvement opportunities.
Participate in vendor qualification and periodic assessment activities in collaboration with Quality and Procurement teams.
Coordinate vendor support activities, issue resolution, and escalation management.
Partner closely with Clinical Operations, Quality Assurance, Regulatory Affairs, Pharmacovigilance, Biometrics, and Technical Operations to optimize business processes through technology.
Act as a trusted advisor to business stakeholders by recommending scalable, compliant system solutions that improve operational efficiency and user experience.
Collaborate with Enterprise Applications, IT Infrastructure, Cybersecurity, Quality, and Data teams to support compliant integrations and enterprise technology initiatives.
Participate in new system implementations, upgrades, and digital transformation initiatives across the clinical technology landscape.