structuretx

structuretx

Senior Manager, Clinical Business Systems

South San Francisco, California · Senior

Sponsorship not specified$166k-$209kDetected 5 hours ago
Stakeholder ManagementProcess ImprovementVendor ManagementProcurementFDA RegulatoryPharmacovigilanceMedical DevicesSASLeadershipCommunicationCollaborationProblem SolvingGxPRegulatory Affairs

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37Unrated
Cap-exempt (no lottery)0
Sponsors this role0
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70

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About the role

  • 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.
  • 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.

Responsibilities

  • GxP Application Administration & Support
  • 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.
  • 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.
  • Support regulatory inspections by providing system documentation, validation artifacts, audit evidence, and subject matter expertise.

Requirements

  • Bachelor's degree in Computer Science, Computer Engineering, Information Technology, Life Sciences, or a related field recommended.
  • 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.
  • 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.
  • 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.
  • 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.
  • Strong documentation, organizational, and problem-solving skills.
  • Experience with Clinical, Quality, and Regulatory business processes in a biotechnology or pharmaceutical environment.

Nice to have

  • Veeva Vault Administrator certification preferred.

Compensation

  • Structure Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive.
  • For this role, the anticipated base pay range is $166,000-$209,000.
  • At Structure, base pay is only one part of your total compensation package.

Benefits

  • The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity.
  • Structure Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, unlimited PTO, and a number of paid holidays including winter shutdown.

Company info

  • 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
  • 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.
  • Remote employees will need to be present for monthly connection weeks, company meetings and/or industry conferences.
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