structuretx
Clinical Trial Manager, Biospecimen DC/MP
South San Francisco, California
Sponsorship not specified$146k-$185kDetected 20 days ago
GCPNegotiationLogisticsVendor ManagementPerformance ManagementClinical TrialsClinical ResearchFDA RegulatoryResearchLeadershipCommunicationCollaborationMicrosoft Office
About the role
- Structure Therapeutics is seeking a highly motivated Clinical Trial Manager (CTM), Biospecimens Management to be part of our Clinical Operations team.
- Biospecimen & Laboratory Strategy Execution
- Translate sample analysis plans into executable operational plans in collaboration with Clinical Development and Translational teams.
Responsibilities
- Identify risks to timelines or deliverables and proactively implement mitigation strategies.
- Manage change orders, scope adjustments, and budget revisions related to lab services.
- Partner with vendors and internal stakeholders to mitigate risks related to sample integrity, stability, and chain of custody.
- Support inspection readiness related to laboratory and biospecimen management.
- Support development and refinement of SOPs related to biospecimen management.
- Support inspection and audit readiness activities.
Requirements
- Strong understanding of clinical trial processes and laboratory operations.
- Knowledge of FDA, EU, ICH/GCP regulations related to biospecimen handling.
- Proficiency in MS Office and clinical systems (EDC, CTMS, eTMF).
- Minimum 7+ years of industry experience in clinical research, laboratory operations, or related function with increasing responsibility.
- Minimum 3+ years of study management or laboratory/vendor oversight experience in clinical drug development.
- Experience overseeing biospecimen logistics, reconciliation, and sample lifecycle management.
- Experience managing vendor budgets and contracts.
- Travel Required: Up to 20%
- Education
- Bachelor's degree or equivalent (scientific or healthcare discipline preferred)
- Experience
- Demonstrated experience managing central labs, specialty labs, or biomarker vendors in global, multicenter trials.
Nice to have
- Experience supporting global studies (US, EU, and/or APAC preferred).
Skills
- Excellent vendor management and negotiation skills.
- Strong cross-functional leadership and communication skills.
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 $146,000 - $185,000.
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:
- Structure Therapeutics is seeking a highly motivated Clinical Trial Manager (CTM), Biospecimens Management to be part of our Clinical Operations team. This role will report directly to the Head of Clinical Operations and serve as the operational lead for biospecimen strategy execution across global clinical trials.
- 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.
- This role will report directly to the Head of Clinical Operations and serve as the operational lead for biospecimen strategy execution across global clinical trials.
- The CTM will be responsible for the end-to-end oversight of laboratory vendors and biospecimen management activities, including central and specialty labs, biomarker vendors, bioanalytical labs, and biobanking partners.
- This individual will ensure seamless sample lifecycle management from collection through analysis, storage, and reconciliation, maintaining compliance with protocol requirements, regulatory standards, timelines, and budgets.
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