Validation Analyst

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 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.     

• Regular and consistent attendance.