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US-NC-Morrisville: Senior Validation Analyst

Date: _27-Aug-2012_
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Senior Validation Analyst

* Requires 4-yr degree in computer, biological or life sciences or related area, or equivalent combination of education, training and professional experience that provides the required knowledge, skills and abilities * Fundamental training, knowledge and experience with systems and software validation processes * 4 years experience with systems or programming tools in use at PPD or within the CRO/Pharmaceutical industry * Experience in clinical research, or alternatively in another highly regulated technical environment

* Client focused approach with strong interpersonal skills * Strong oral and written communication skills and ability to teach others * Strong attention to detail and problem solving skills * Competent with MS Word, MS Excel, MS PowerPoint, MS Project * Demonstrates positive attitude, enthusiasm toward work and the ability to work well with others * Good organization skills and time management skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines * Good understanding of clinical trials operational processes and terminology * Good understanding of software development life cycle (SDLC) * Proven ability to learn new computer software with minimum of instruction * Strong troubleshooting skills needed to analyze software defects and the ability to explain how errors are produced * Ability to attain, maintain and apply a working knowledge of GCPs, applicable SOPs/WPDs, and Process Maps * Ability to review and critique SDLC documentation including Requirements, Functional Design, System Design, and Test Plans * Ability to assess the cause of test failures * Demonstrated ability to coordinate project activities and work and communicate effectively on a multi-disciplinary team * Ability to realize validation process needs and provide solutions * Demonstrated experience in identification and resolution of technical problems in a professional environment * Ability to develop and maintain Project Schedules within MSProject * Must be able to set and meet timelines and be able to negotiate schedule changes in response to project

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