Clinical Sample Manager
Horizon Therapeutics - Rockville, MD
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Working at Horizon is more than a job - it''s personal. For us, success is measured by the numbers that matter most - the number of lives we touch, the number we change and those we work tirelessly to help save. We''re a team of agile, out-of-the-box thinkers who are inspired to do more because we know we''re a part of something bigger. We strive to build meaningful careers at a company whose values we share because when we live up to our potential, we help others live up to theirs. Position Summary: This role of Sample Manager includes oversight of all aspects of sample handling (planning, requesting, reconciling, receiving, organizing, tracking, shipping and storing) of human biological samples from Horizon interventional clinical trials or academic collaborations to enable testing and biomarker driven insights into our molecules. Horizon is a patient centric company, and this commitment extends to ensuring every patient sample counts. This appointment requires a strong commitment to end to end oversight of human biological samples to ensure sample quality, compliance, traceability, and data integrity. This role requires a detail orientated, highly organized and systematic manner coupled with a strong ability to communicate and collaborate with internal and external stakeholders to ensure a coordinated science-based approach to sample collection, testing and retention. Project management skills and familiarity with establishing and/or using inventory or specimen tracking systems is required.Responsibilities:Establish and maintain sample receipt, reconciliation, storage, and chain of custody tracking of human biological samples to HorizonGeneration of electronic sample receipt documents and manifestsCollaborate with IT to establish a functional sample management systemEstablish, maintain, and update electronic systems to track sample storage for life span of a sampleMonitor and maintain inventory to demonstrate compliance with informed consent records; scheduling and documenting destruction of samples removed from in-house or external inventories as requiredCoordinate long term archiving of samples from Horizon to off-site storage facilityBiological sample procurement from vendors including quotes, orders, receiving and logging samples, and tracking samples in inventoryCoordination of biological sample shipment from clinical sites, academic centers or central lab to Horizon or third-party testing labsSample reconciliation prior to in-house or external sample testingTrack testing contract status and engage with translational scientists, third-party vendors, and key functional stake holders to enable execution of biomarker sample testing plansCommunication and coordination with scientific teams including data managers, programmers, clinical coordinators, translational scientists, and third-party vendors to ensure samples (and accompanying data) are transferred between Horizon and sample testing municating and tracking factors that may affect quality, accuracy, timeliness, and usefulness of pliance with HBS regulations, including consent reviewHBS audit preparation and documentation to ensure inspection readinessLong-term archiving of samples and biobank inventory maintenanceQualifications and Skills Required:Prior laboratory experience dealing with clinical samplesExperienced with and comfortable handling human biological material (BSL2)Prior experience establishing and/or using with inventory or sample management or LIMS systems is requiredStrong organizational skills to ensure samples are tracked and traced for life span of the sample.Scientific or clinical background in life sciences (Bachelors + 10-12 years or Masters + 8-10 years); immunology training preferred but not requiredPrior work with HBS and familiarity with HBS regulationsHighly skilled at Microsoft Excel; able to create and manage styles, permissions, macros etc.Proven planning, time management and project management capabilitiesAbility to work productively in a matrixed multidisciplinary scientific team environmentStrong interpersonal, communication skillsProficient in normal office software; Microsoft Word, Outlook, PowerPointProfessional, proactive demeanor.Strong interpersonal skills.Excellent written and verbal communication skills. Horizon Core Values & Competencies: Growth Manages Ambiguity Strategic Mindset Demonstrates Self-awareness Cultivates Innovation Develops Talent Accountability Drives Results Ensures Accountability Decision Quality Transparency Courage Collaboration Instills Trust Horizon requires all U.S. employees to be fully vaccinated, as a condition of employment, with either Pfizer (fully approved by the U.S. Food and Drug Administration), Moderna or Johnson & Johnson (currently granted emergency-use authorization by the FDA). ''Fully vaccinated'' is defined as two weeks after your final dose of the Pfizer, Moderna, or Johnson & Johnson vaccine. Horizon will provide medical and religious accommodations as required by law. Horizon Therapeutics plc does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.
Created: 2025-10-04