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.