ERT

Validation Analyst

US-PA-Philadelphia
Shift
Mon-Fri 8:30-5pm
Type
Regular Full-Time

Overview

ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that our customers can move ahead with confidence. With more than 45 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so it can adapt without compromising standards.

Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement, and measure the efficacy of new clinical treatments while ensuring patient safety. Over the past four years, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, Biotechs, and CROs have relied on ERT solutions in 9,500+ studies spanning three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly – and with confidence. For more information, go to ert.com or follow us on LinkedIn, Twitter, and Facebook.

 

ERT is looking for a Validation Analyst for our Philadelphia office.  In this role, you will perform validation activities for internal clinical data systems, third party vendor systems, and Patient Reported Outcome configurations.

Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  1. 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: Validation Protocol, Test Scripts, Validation Summary, Deviations and Traceability.
  2. 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.
  3. Document and communicate deviations found during testing and maintain comprehensive tracking of all test deviations and associated corrective actions.
  4. Interact with in-house development and operational staff in the development of system specifications and documentation.
  5. Support Quality Assurance department with client audits by providing validation documentation, clarification of testing procedures or system demonstrations as needed.
  6. 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.
  7. Execute test scripts and/or review results of test scripts to ensure accurate and complete testing documentation.
  8. Perform ongoing quality reviews of clinical data systems or Patient Reported Outcome configurations.
  9. Coordinate with operational management in the identification, oversight, and training of end users in the execution of test scripts.
  10. Provide internal training services or consulting services to contracted external sources as required.

 

The duties and responsibilities listed in this job description represent the major responsibilities of the position.  Other duties and responsibilities may be assigned, as required.  This job description and any attachments do not constitute or represent a contract.

Qualifications

QUALIFICATIONS AND SKILLS NEEDED

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

 

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. 

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