Clinical Biomarker and Diagnostics Operations Senior Associate

2 days ago

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Amgen

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Biologics • Human therapeutics • Development of novel products

10,000+

💰 Post-IPO Debt on 2022-12

Description

• Support continuity and integrity across projects, coordinate assay development and implementation activities • Act as primary contact for operations in projects requiring biomarker and diagnostic activities • Drive implementation of biomarker and diagnostic plans for therapeutic programs • Accountable for development of biosample collection and processing strategies • Plan and implement biosample collection including material definition and database setup • Ensure data consistency with plans and protocols • Develop sample reconciliation plans and manage data reporting • Provide regular reports on sample tracking for analysis • Contribute to study protocols and ensure enabled sample testing • Participate in site initiation visits to train sites on sample collection • Project manage implementation of clinical trial assays at labs and vendors • Manage contracts, budgets, and timelines for biomarker activities

Requirements

• Master’s degree OR Bachelor’s degree and 2 years of experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment OR Associate’s degree and 4 years of experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment OR High school diploma / GED and 6 years of experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment • Life Sciences degree (higher qualification e.g. MSc or equivalent preferred) • Further qualification, e.g. project management certification is desirable • 2+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment • Prior clinical development experience of working in teams running clinical studies • Clinical or biological laboratory experience with involvement in the processing and/or analysis of biological samples • Project management skills and knowledge of project management tools • Critical reasoning skills including the identification and resolution of complex problems • Meticulous with the ability to work under general direction and manage multiple competing priorities • Excellent planning, organizational and time management skills • Effective communication skills

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • A discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models, including remote and hybrid work arrangements, where possible