Validation Analyst
PharmaClinical ResearchQuality Assurancegcpemacroraveinform
Job description
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Qualifi c a t i o n s: E du c a tion a n d E xp e ri e nc e : Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years). In s o m e c as e s, an e q u ival e n cy , c o n si s t in g of a c o m b i n at i o n of a p propr i a t e e d u c at i o n , tra in i n g a n d/or dire c t l y r e la t e d e xp e rienc e , wi l l be c o n sider e d s u f f ici e n t for an i n divid u al t o m ee t th e r e q u ire m e n ts of t h e rol e . Knowl e dg e , Skills, a n d A b i liti e s : Client focused approach with strong interpersonal skills, and strong oral and written communication skills and ability to teach others Strong attention to details and problem-solving skills Demonstrated competency with Microsoft Office Suite (Word, Excel, PowerPoint, and Project). Proven ability to learn new computer software with minimum of instruction Positive attitude, enthusiasm toward work, and the ability to work well with others Strong organization and time management skills with the ability to adapt and adjust to changing priorities and manage multiple assignments with challenging/conflicting deadlines Solid understanding of clinical trials operational processes and terminology and solid understanding of the software development life cycle (SDLC) Strong troubleshooting skills and ability to analyze software defects, assess the cause of test failures, and 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 Policy and Strategy : Policy Strategy > Management Role : No management responsibility W or k ing C o n d i t i o ns and Env i ro n m e n t : 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 : Frequently stationary for 6-8 hours per day. 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
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