Support Clinical Affairs Teams by ensuring that software is developed according to good design practices and follows the requirements set forth by procedures, regulatory authorities and is compliant with all FDA guidelines for software validation and data integrity. Key responsibilities include:
- Provide oversight and training for computerized system validation deliverables both internally and externally
- Develop and document Test Plans, Test Specifications, Test Results, Test Summary Reports, and supporting test documentation
- Perform software testing and validation as appropriate. Ensure testing processes are documented appropriately and adhere to the W.L. Gore & Associates Quality System requirements
- Interface with a multi-faceted project team throughout software implementation and maintenance process
- Prepare and maintain required Internal Quality System and regulatory documentation
- Perform timeline management, tracking and release schedules to keep projects on schedule while minimizing delays and mitigating risks
- Develop testing tools and test data sets that help streamline the testing process
- Provide Electronic Data Capture (EDC) user system administration oversight ensuring consistent processes and appropriate training occur while retaining proper documentation
- Develop forums to communicate information on clinical systems software solutions
- Participate in Clinical Affairs Process Improvement initiatives
Required
- Bachelor's degree in CIS, MIS, CS, EE or 5 years equivalent experience
- Experience in application and database testing preferably in the Biotech, Medical Device, or Pharmaceutical industry
- Successful experience working on cross-functional teams
- Strong verbal and written communication skills
- Strong organizational skills, flexibility, and ability to multi-task
Preferred
- Thorough working knowledge of 21 CFR Part 11 and all applicable regulations. Good understanding of GCP's and ICH with respect to clinical processes and systems.
- Working knowledge of the device development process and clinical trial operations
EEO/AA Employer (applies to all positions located in the U.S.)
