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Test Analyst
JPC Partners is looking for a Testing Analyst that will be responsible for testing project specific study configurations and protocol amendments. We are looking for individuals that possess the following qualifications:
- 2-3 years’ experience in a similar quality management or testing role.
- Must have 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.
- 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
- 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.