IT Project Manager Lead Consultant

2 mesi fa

Provincia di Roma Lazio, Italia ClinChoice A tempo pieno

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 12 months Contract with possibility of extension **to join one of our clients.

**Main Job Tasks and Responsibilities**:
An IT Project Manager 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 establishing and/or overseeing IT QA program schedules, technical performance; preparing and implementing IT QA plans; performing IT QA reviews. This includes, but is not limited to:

- 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.
- 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.
- Writing documentation or reviewing 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.

**Education and Experience**:

- 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.

**The Application Process**:
**Who will you be working for?**

**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 and close management and training is the core instrument to develop and maintain highly-qualified personnel. The 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,

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