Validation Analyst

• Write concise and complete documentation to support the validation for internal clinical data systems, third party vendor systems or Patient Reported Outcome configurations. Documentation would include but is not limited to: Test Strategies, Test Reports, Test Summary Reports, Deviations and Traceability.

• Evaluate new and updated systems or configurations to determine the necessary validation steps to assure compliance of those systems or configurations with industry standards and regulatory requirements.

• Document and communicate deviations found during testing and maintain comprehensive tracking of all test deviations and associated corrective actions.

• Interact with in-house development and operational staff in the development of system specifications and documentation.

• Support Quality Assurance department with client audits by providing validation documentation, clarification of testing procedures or system demonstrations as needed.

• Assist in the development of standard operating procedures related to the development, configuration, evaluation, implementation, and testing of clinical data systems or Patient Reported Outcome configurations.

• Review results of test reports to ensure accurate and complete testing documentation.

• Execute test reports to confirm system functionality is functioning as expected and meets the requirements of intended use.

• Perform ongoing quality reviews of clinical data systems or Patient Reported Outcome configurations.

• Coordinate with operational management in the identification, oversight, and training of end users in the execution of test scripts.

• Provide internal training services or consulting services to contracted external sources as required.

What we look for

• College Degree in Computer Science, Information Technology, Health/Life Sciences or Biomedical Engineering.

• 3-5 years experience in a validation role or related job experience.

• Knowledge of GCPs, 21CFR Part 11 and related electronic record requirements desired.

• Excellent organizational and communication skills.

• Detail oriented.

• Proficiency in Microsoft Word, Microsoft Excel and PowerPoint.

• Experience with IVR and PRO systems a plus.

• Familiarity with database software design and concepts.

At Clario, we put people first, always. We are united and driven by patients, committed to making a difference, and we are always looking for the best talent to help us transform lives. We value the contribution each of our people brings. It s only through our people that we can continue to innovate technology that will shape the future of clinical trials.