Clinical Trial Manager, Biospecimen

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:

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.

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.

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

Job Responsibilities

Biospecimen & Laboratory Strategy Execution

• 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.

Laboratory Vendor Oversight

• 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.

Sample Lifecycle & Flow Management

• 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.

Compliance & Quality

• 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 (e.g., eTMF, CTMS).
• Support inspection and audit readiness activities.

People Leadership

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

Qualifications:

Education

• Bachelor's degree or equivalent (scientific or healthcare discipline preferred)

Experience

• 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.
• Demonstrated experience managing central labs, specialty labs, or biomarker vendors in global, multicenter trials.
• Experience overseeing biospecimen logistics, reconciliation, and sample lifecycle management.
• Experience managing vendor budgets and contracts.
• Experience supporting global studies (US, EU, and/or APAC preferred).

CORE COMPETENCIES, KNOWLEDGE AND SKILL REQUIREMENTS

• Strong understanding of clinical trial processes and laboratory operations.
• Knowledge of FDA, EU, ICH/GCP regulations related to biospecimen handling.
• Excellent vendor management and negotiation skills.
• Strong cross-functional leadership and communication skills.
• Detail-oriented with strong risk identification and mitigation capabilities.
• Proficiency in MS Office and clinical systems (EDC, CTMS, eTMF).

Travel Required: Up to 20%

Structure Therapeutics Inc. is an Equal-Opportunity Employer.

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. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's geography, qualifications, skills, and experience.

At Structure, base pay is only one part of your total compensation package. 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.

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