Lexeo Therapeutics
Advancing science with curative potential for both cardiovascular and APOE4 associated Alzheimer's disease areas.
11 - 50
Clinical Operations Bio-sample Manager - Contractor
August 21
🔄 Hybrid – Manhattan
Lexeo Therapeutics
Advancing science with curative potential for both cardiovascular and APOE4 associated Alzheimer's disease areas.
11 - 50
Description
• Function as the subject matter expert to support the operationalization of clinical bio-sample activities across Lexeo’s clinical programs • Independently collaborates across clinical study teams, functions, and departments • Be the key point of contact for biosample activities keeping the teams informed to enable data driven decision making. • Ensure efficient biosample logistics from study set-up through data delivery and study close-out • Management of day-to-day operational routine activities delegated to biosample vendors including vendor management and oversight, performance management, escalation of issues • Ensures standardization and harmonization of bio-sample processing and throughput activities across clinical trials for optimal sample accrual and quality • In consultation with Bioanalyitcs teams, clinical study team, and other key stakeholders, provides input for lab vendor selection, lab vendor management and oversight of the long-term storage vendor • Contributes to the budget development, review invoices against work completed, support financial accrual activities • In consultation with Clinical Study Team, plans and co-ordinates delivery of bio-samples and associated data to align with trial objectives and critical trial operation milestones • Knowledgeable of sample import/export requirements relative to study team’s country selection • Co-creates and/or implements a program/trial level Clinical Operations Bio-sample management plan that aligns with trial/program objectives, and compliant with Lexeo SOPs, ICH/GxP/GLP/GDP • Ensures development and availability of laboratories’ vendor management plans per Lexeo SOPs and established templates • Provides input on relevant bio-sample information required for development of study Informed Consent templates • Creates and/or leverages tracking systems to report progress, address issues and resolutions • Oversees, facilitates, and tracks door-to-door sample disposition i.e., investigative sites, couriers, and laboratories for local/regional and global clinical trials of moderate to high complexity • Anticipates, identifies, escalates, and provides actionable recommendations for issues that may impact bio-sample quality, analysis/data integrity, custody of samples, timelines, cost, etc • Develops and/or leverages appropriate systems, standards, training modules, and processes to ensure quality and data integrity • Other duties as assigned
Requirements
• Minimum of BA/BS degree in a scientific field or other comparable degree or scientific education, with 4 years of clinical bio-sample management experience, in Gene Therapy • Experience working in a matrix environment, with competing priorities, managing stakeholder expectations and requirements. • Proficient knowledge of clinical drug development processes, clinical protocols and study design, study planning and management. • Proficient project and risk management skills • Proficient interpersonal, written, and verbal communication, and technical skills. • Proficient computer skills i.e., MS Word, PowerPoint, Excel; MS Project/Smartsheet a plus • Entrepreneurial spirit, comfortable working with minimal supervision in a fast-paced global Clinical Operations environment.
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