Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice is searching for an IT Project Manager Lead Consultant for a 12-month contract with the possibility of extensionto join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
Main Job Tasks and Responsibilities:
- Implement software systems in conformance with regulatory requirements as they pertain to CFR 21 Part 11.
- Ensure compliance with corporate initiatives and company standards.
- Develop and maintain a comprehensive IT Quality Assurance Program in support of the company's pipeline.
- Establish and/or oversee IT QA program schedules and technical performance.
- Prepare and implement IT QA plans and perform IT QA reviews.
- Assist in the implementation of software, module by module, and ensure systems function as intended.
- Provide training as necessary for other members of the IT staff.
- Ensure cost-effective compliance with quality standards.
- Provide support for all IT functions associated with Quality.
- Analyze, define, and document system requirements for data, workflow, logical processes, hardware and operating system environment, interfacing with other systems, internal and external checks, controls, and outputs.
- Write and maintain functional and technical specifications as well as other validation documentation as may be required.
- Analyze and estimate feasibility, cost, time, and compatibility with other systems and computer capabilities.
- Develop and maintain plans outlining steps and timetables for developing, testing, and installing applications.
- Assist to create test transactions and run tests to find errors and confirm programs meet specifications.
- Consult with suppliers to prototype, refine, test, and debug programs to attain CFR 21 Part 11 compliance/approval.
- Write and maintain documentation to describe program development, logic, coding, testing, changes, and corrections.
- Provide technical assistance by responding to inquiries regarding errors, problems, or questions with programs.
- Monitor performance of programs after implementation.
- Plan and prepare technical reports, memoranda, and instructional manuals as documentation of program development.
- Assist in other duties as necessary.
Education and Experience:
- Bachelor's 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.
The Application Process
Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built. Close management and training are the core instruments to develop and maintain highly-qualified personnel. Continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
Key words:IT, Project Manager, IT QA
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