Test Analyst

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Test Analyst

Our clients Interactive Response Technology (IRT) project pipeline is growing almost exponentially. The Testing Analyst is responsible for testing project specific study configurations and protocol amendments within the IRT System. We are looking for individuals that possess the following qualifications:
 

• Experience with and demonstrated understanding of computer systems and software application implementation including knowledge of software development life cycle.
• Strong communication skills, job requires communication with internal stakeholders and vendors
• 2-3 years’ experience in a similar quality management or testing role.
• Must have 3+ years’ experience working at a CRO or pharmaceutical company on clinical research and development projects with experience using IRT, EDC, or ePRO Systems.
• Knowledge of clinical research industry, standard practices and GHC, ICH/GCP guidelines and FDA Regulations.
• Knowledge and understanding of regulations associated with clinical trial data handling, including HIPAA, GDPR and 21 CFR Part 11.
• Product, technology or industry expertise relevant to IRT or EDC, preferred but not required.
• Knowledge of clinical studies and trial design preferred but not required.
• Able to review and interpret clinical trial documentation (e.g. protocols), preferred but not required.
• Familiarity with Quality Management, Test Manager or other management system tools, preferred but not required.