EDC Test Analyst

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October 24

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Celerion

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Celerion is a global leader in clinical research services with a focus on accelerating drug development through translational medicine. The company offers a range of services including early phase clinical trials, bioanalytical sciences, PK/PD studies, biomarkers, and regulatory affairs. Celerion is dedicated to getting drugs to market faster by leveraging their experience and innovative research strategies. Their expertise covers various therapeutic areas such as oncology, metabolic and respiratory diseases, biosimilars, and vaccines. With over 40 years of experience, Celerion has been recognized for their leadership in the clinical research organization (CRO) space and is committed to science and technology-driven innovations that advance healthcare solutions globally.

1001 - 5000 employees

Founded 1971

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Perform comprehensive User Acceptance Testing (UAT) on clinical databases and related systems • Create and execute detailed test scripts based on database specifications • Coordinate with CDMs participating in UAT – providing them with test schedules, test data, direction, and detailed test scripts in accordance with study timelines • Validate database libraries and system configuration changes per GxP requirements • Maintain complete validation documentation in compliance with departmental SOPs • Collaborate with multidisciplinary study teams to establish and meet timelines • Proactively identify risks and escalate issues to management and study team members • Communicate progress updates and coordinate testing schedules with stakeholders • Deliver all study deliverables on time per agreed timelines • Analyze system needs and evaluate workflow solutions • Participate in onboarding and validation of new systems and processes • Assist with the validation of upgrades to hardware/ software including validation documentation development, review and execution.

🎯 Requirements

• Bachelor's degree in IT or related field, or equivalent internal or external experience in lieu of a degree • 3-5 years industry experience • Software validation or manual testing background • Exceptional attention to detail and organizational skills • Ability to juggle multiple projects simultaneously • Strong written and verbal communication skills • Proficiency in MS Office applications • Knowledge of Good Clinical Data Management Practices, Medical Terminology, GCP, ICH Guidelines, and 21 CFR Part 11 is preferred

🏖️ Benefits

• Celerion Values: Integrity, Trust, Teamwork, Respect