Validation Analyst

Minimum Required Education and Experience. 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. 2 years experience with systems or programming tools in use at PPD or within the CRO/Pharmaceutical industry. 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. Qualifications. Required Knowledge, Skills and Abilities. Work is performed in an office environment with exposure to electrical office equipment. Occasional drives to site locations with occasional travel both domestic and international. Physical Requirements. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequent mobility required. Occasional crouching, stooping, bending and twisting of upper body and neck. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others to obtain or relate information to diverse groups. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration. Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multitask.