Clinical Sample Manager

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SAB BIO

WebsiteLinkedInAlle Stellen

51 - 200 Mitarbeiter

Gegründet 2014

🧬 Biotechnologie

💊 Pharmazie

🏥 Gesundheitswesen

Biotechnology • Pharmaceuticals • Healthcare

SAB BIO ist ein biopharmazeutisches Unternehmen in der klinischen Entwicklungsphase, das sich auf die Entwicklung multi-spezifischer, hochwirksamer humaner Immunglobulin G (hIgG)-Therapien konzentriert, um Immun- und Autoimmunerkrankungen zu behandeln und zu verhindern. Ziel ist es, die Diagnose und Behandlung von Typ-1-Diabetes (T1D) durch krankheitsverändernde Medikamente neu zu definieren. Gegründet im Jahr 2014 und seit 2021 an der Nasdaq (SABS) notiert, nutzt SAB BIO proprietäre Technologien der genetischen Entwicklung und Antikörper zur Generierung therapeutischer Kandidaten, ohne auf menschliche Spender oder Rekonvaleszenz-Plasma angewiesen zu sein. Das Unternehmen hat sieben klinische Studien durchgeführt, in denen etwa 700 Personen in verschiedenen therapeutischen Bereichen dosiert wurden, und berichtet über keine Patienten mit Serumkrankheit oder neutralisierenden Anti-Drug-Antikörpern in seiner Sicherheits- und Immunogenitätsdatenbank. Der führende Kandidat, SAB-142, zielt darauf ab, das Fortschreiten von T3D im Stadium 3 zu verzögern und möglicherweise zu verhindern.

Beschreibung

• Provide operational oversight of assigned clinical trial service providers, ensuring services are delivered according to study requirements, quality standards, and timelines. • Serve as the primary clinical operations point of contact for clinical trial laboratory vendors. • Oversee clinical trial laboratory vendor activities from study startup through closeout, including laboratory setup, laboratory manual development, kit design, sample collection requirements, test result reporting, and data delivery. • Serve as the primary point of contact for laboratory-related clinical trial operations for internal and external study teams, overseeing key operational deliverables, including laboratory manuals, data transfer specifications, sample management plans, vendor operational plans, and study-specific training materials. • Review and provide operational input into clinical protocols, informed consent forms, and other study-related documents. • Oversee sample management activities, including site supply management, kit ordering, sample shipment tracking, laboratory result reporting, and issue resolution. • Coordinate with internal stakeholders and external vendors to ensure proper handling of clinical laboratory samples, including specialty samples such as pharmacokinetic (PK), pharmacodynamic (PD), biomarker, immunogenicity, genetic, and safety laboratory samples, as applicable. • Partner closely with Clinical Operations study teams to support the successful execution of clinical trial activities. • Collaborate with Clinical Operations, CROs, investigative sites, laboratory vendors, and other stakeholders to ensure effective planning and execution of study-related operational activities. • Monitor clinical site performance and support site-facing communications related to laboratory procedures, sample collection requirements, shipping instructions, and process changes. • Oversee the quality, completeness, and timeliness of clinical trial laboratory data and data transfers from vendors to internal systems, data management platforms, and electronic data capture (EDC) systems. • Support laboratory and vendor data reconciliation activities, including sample reconciliation, missing data follow-up, query resolution, and review of out-of-range or clinically significant laboratory results. • Ensure vendor services and deliverables are aligned with protocol requirements, regulatory requirements, and study objectives. • Work cross-functionally with Clinical Development, Quality Assurance, Regulatory Affairs, Finance, and external vendors to ensure activities are conducted in compliance with study protocols, vendor agreements, ICH-GCP, regulatory requirements, and company standards. • Partner with Clinical Development, Clinical Operations, and Finance to support contracting activities, budget management, change order review, and invoice reconciliation. • Escalate vendor performance issues, operational risks, and quality concerns as appropriate, and drive corrective and preventive actions through resolution. • Other duties and responsibilities as assigned.

🎯 Anforderungen

• Bachelor’s degree in life sciences, laboratory science, or a related field. • 5+ years of relevant and progressively responsible experience in clinical operations, clinical laboratory operations with 2+ years clinical trial sample management experience within the biotechnology, pharmaceutical, CRO, or laboratory industry required. • Experience managing central laboratory, clinical laboratory, or specialty laboratory operations/data/vendors in support of clinical trials. • Strong understanding of clinical research, clinical trial operations, laboratory sample workflows, and site/vendor logistics. • Understanding of ICH-GCP, regulatory requirements, clinical trial documentation standards, and inspection readiness expectations. • Experience with clinical data systems, clinical laboratory data, data transfer specifications, and data reconciliation processes. • Demonstrated ability to manage vendors, timelines, budgets, deliverables, risks, and cross-functional communications. • Ability to multitask, manage multiple studies, vendors, and priorities simultaneously and work in a fast-paced team environment. • Excellent organizational skills and attention to detail and to consistently deliver work product accurately and within deadline. • Excellent written and verbal communication skills. • Demonstrated proficiency using Microsoft Office applications (Word, Excel, PowerPoint), etc. • Experience with Smartsheet and laboratory information management systems preferred

🏖️ Vorteile

• Generally accepted home office working conditions • Occasional domestic and international travel is expected in this position