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.