Clinical Trial Manager, Biospecimen DC​/MP

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.

We are seeking a highly motivated Clinical Trial Manager (CTM), Biospecimens Management to be part of our Clinical Operations team. The role reports directly to the Head of Clinical Operations and serves as the operational lead for biospecimen strategy execution across global clinical trials.

The CTM will be responsible for end‑to‑end oversight of laboratory vendors and biospecimen management activities, including central and specialty labs, biomarker vendors, bioanalytical labs, and biobanking partners. The individual will ensure seamless sample lifecycle management from collection through analysis, storage, and reconciliation, maintaining compliance with protocol requirements, regulatory standards, timelines, and budgets.

This role requires strong cross‑functional collaboration with internal stakeholders and external partners to ensure alignment on sample analysis plans and operational feasibility.

• Lead operational implementation of biospecimen strategy across assigned clinical programs.
• Translate sample analysis plans into executable operational plans in collaboration with Clinical Development and Translational teams.
• Ensure alignment between protocol requirements, laboratory manuals, and vendor capabilities.
• Oversee development and review of laboratory manuals, sample collection guidelines, and kit specifications.
• Ensure laboratory timelines are aligned with overall clinical study timelines.
• Identify risks to timelines or deliverables and proactively implement mitigation strategies.

• Participate in RFI/RFP processes for central labs, specialty labs, biomarker vendors, and bioanalytical partners.
• Evaluate proposals, participate in bid defense meetings, negotiate scopes of work, budgets, and contracts.
• Provide day‑to‑day oversight of laboratory vendors to ensure performance against timelines, quality expectations, and contractual obligations.
• Manage change orders, scope adjustments, and budget revisions related to lab services.
• Monitor vendor KPIs and ensure timely issue identification, escalation, and resolution.

• Oversee global sample flow logistics including collection, processing, shipment, tracking, reconciliation, analysis, and storage.
• Ensure sample tracking systems and reconciliation processes are accurate and audit‑ready.
• 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.

• Ensure biospecimen and laboratory operations comply with ICH/GCP, regulatory requirements, and company SOPs.
• Support development and refinement of SOPs related to biospecimen management.
• Ensure accurate documentation in study systems (eTMF, CTMS).
• Support inspection and audit readiness activities.

• Directly manage and develop junior members of the Biospecimen Management function, including hiring, onboarding, performance management, and career development.

• Bachel…