IT Project Manager Lead Consultant

Job Description

ClinChoice is seeking an IT Project Manager Lead Consultant for a 12-month contract, with a possibility of extension, to join one of their clients. This role offers the unique opportunity to work directly with a single sponsor while benefiting from the security and career opportunities of a global CRO.He/she will be responsible for implementation of software systems in conformance with regulatory requirements as they pertain to CFR 21 Part 11. Further, he/she will be responsible for ensuring compliance with corporate initiatives and company standards as well as develop and maintain a comprehensive IT Quality Assurance Program in support of company's pipeline.Responsibilities include:

• Assisting in the implementation of software, module by module, and ensuring systems function as intended.
• Providing training as necessary for other members of the IT staff.
• Ensuring cost-effective compliance with quality standards.
• Providing support for all IT functions associated with Quality.
• Analyzing, defining, and documenting system requirements for data, workflow, logical processes, hardware and operating system environment, interfacing with other systems, internal and external checks, controls and outputs.
• Writing and maintaining functional and technical specifications as well as other validation documentation as may be required.
• Analyzing and estimating feasibility, cost, time, compatibility with other systems and computer capabilities.
• Developing and maintaining plans outlining steps and timetables for developing, testing and installing applications.
• Assisting to create test transactions and running tests to find errors and confirm program meeting specifications.
• Consulting with supplier to prototype, refining, testing and debugging programs to attain CFR 21 Part 11 compliance/approval.
• Writing and maintaining documentation to describe program development, logic, coding, testing, changes and corrections.
• Providing technical assistance, to the extent capable, by responding to inquiries regarding errors, problems or questions with programs.
• Monitoring performance of programs after implementation.
• Planning and preparing technical reports, memorandum and instructional manuals as documentation of program development.
• Assisting in other duties as necessary.

Requirements:

• Bachelor Degree in Computer Science or equivalent work experience.
• 5 years of testing and IT experience within a computing environment including experience creating new test-scripts and modifying existing test-scripts.
• Effective analytical skills and ability to extrapolate information from written documents when information is missing, convoluted and/or unclear.
• Effective verbal and written communication skills.
• Ability to clearly document and report testing-effort results.
• Ability to work independently or as part of a team in the resolution of problems and completion.
• Knowledge of IT QA procedures and processes including acceptance testing procedures, defect tracking, benchmarking, process simplification and effectiveness improvement, customer satisfaction measurements.
• Knowledge of software release management and software development life cycle processes.
• Knowledge of software development and deployment processes.