- Supports validation activities as assigned and serves as a validation team member.
- Review to make oneself familiar with the EDC specifications.
- Writes and assembles validation documentation packages such as but not limited to, validation plan, testing results, traceability matrix, validation reports.
- Support virtual global validation team as needed to complete validation projects
- Maintains and utilizes knowledge of SOPs and validation procedures/standards in relation to system development cycle.
- Executes test cases against requirement, enters errors in error tracking logs and performs re-test documenting resolutions.
- Supports in maintaining testing documentation and files.
- Carry out all activities according to Covance SOPs working within the framework of the Quality Management System and to Good Clinical Practice (GCP).
- Perform other duties as assigned by senior staff and/or manager.
- University/college degree (life science, computer science, programming, pharmacy or related subject preferred), or certification in a related profession from an appropriately accredited institution (e.g., nursing certification, computer science, medical or laboratory technology)
- Basic knowledge of drug development process and Clinical Data Management System.
- Basic knowledge of relational databases preferred
- Fluent in English, both written and verbal
- Two to Four (2-4) relevant work experience to include data management and database support:
- Good problem solving skills and a proactive approach
- Good oral and written communication skills
- Basic knowledge of clinical trial process to support operations preferred
- Ability to work in a team environment
- Ability to work effectively under supervision
- Ability to prioritize work
- Good time management skills and maintain the highest standards of quality work
- A cooperative and team oriented approach
Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed