Validation Analyst

Qualifications: 

Education and Experience: 

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 some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. 

Knowledge, Skills, and Abilities: 

• 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 

Working Conditions and Environment: 

• 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.