Education AS or BS in computer science, mathematics, information systems, information technology or a related field is preferred. ISO and GxP training is required
SEI CMMI training is preferred
Minimum of 3-6 years of computer system validation experience in clinical systems / GxP regulated environment is required
Minimum of 3-6 years of creating and executing test scripts, validating test results and managing defects is required
Knowledge of Software Development Life Cycle (SDLC) is required
Software programming background is preferred.
Testing.Responsible for writing, executing and documenting test plans/test scripts based upon written functional requirements for various Laboratory Management and Clinical Trials Management software systems/projects in a fast paced work environment. Responsible for reviewing all Software Development Life Cycle (SDLC) deliverables, provide constructive feedback, and ensure that the deliverables adhere to associated regulations and company’s Standard Operating Procedures (SOPs). Responsible for the development of system documentation and perform system analysis function.
Change Management.Facilitate, support and maintain the Change Management process for Information Technology department
Guidance & Coordination.Coordinate and communicate testing efforts for new projects and system upgrades within IT department and other internal /external customers