Project Manager, System Implementation & Compliance
Premier Research - Florida

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This position will have one primary area of responsibility: project management for system implementation and validation projects for regulated and non-regulated systems for cross-departmental systems, and processes regulated by local and international regulations. Secondary areas of responsibility include: Cross-departmental systems analysis and system documentation development, and assistance as applicable to phases of a standard System Development Lifecycles (SDLC); cross-departmental; and validation management, assistance and document development.

System Implementation Project Management

Works with Head of System Implementation and Compliance identifying project tasks and implementation approaches

Develops project timelines, resources, and expected vs. actual project costs

Manages implementation projects and coordinating all project team members and activities to successful completion

Reports to the VP of IT and Head of System Implementation and, stakeholders, and SOC on project progress

Validation Management

Manages validation projects as above

Develops/assists in the development of key validation deliverables including but not limited to: Validation plans, requirements/specifications, IQs, OQs, PQs, and validation summary reports

Participates in validation ongoing operational activities such as change management, admin/maintenance reviews/monitoring, periodic reviews, etc.

Manages field client audits as they pertain to validation activities

Develops and/or assists in the development of SOPs/WGs/ADs

System Analysis

Works with users, developers, administrators to develop/assist in the development of: User requirements/design/functional specifications, system test plans/test scripts

Works with above roles in the execution and documentation of test scripts

Interfaces on a regular basis with above roles as well as the IT Infrastructure Team, IT Service Support Team, IT Operations, System Owners, QA, Strategic Sourcing, Information Technology Client Services (ITCS) Group and the Technical Steering Committee (TSC)

Must be available to perform up to 30% overnight business travel, as required

Required Skills

Required Experience

Bachelor's Degree in information technology or computer science preferred

Minimum of 7+ years experience in large and small scale system development, integration, and operation within a regulated industry

Minimum of 5+ years managing validation projects from start to finish, completing associated documentation, fielding client audits and performing vendor assessments, including:

Managing project tasks, resources and budgets utilizing known project management tools (MS Project, Excel, etc.)

Gathering and writing functional and system requirement documentation, ERD, DFD, pseudo logic, risk assessments, traceability matrices, bug tracking, validation plans, protocols, final reports, system support documentation, network diagrams

System testing and test script development for web and non-web based technologies including: unit, functional, performance, capacity, stress, and installation

Developing Policies/SOPs and typical validation associated documentation (IQ, OQ, PQ)

Current working knowledge of current GxP and European Union regulations as they pertain to computerized systems

Experience in at least one generally accepted standard for software/system development, service delivery, and validation methodologies i.e. PDA, GAMP, ISO9000, IEEE, ITIL, CobIT, ASQ

Familiarity/experience in with the following systems/supporting systems a plus: Clinical Data Management, Common GxP Applications, Software Development, CTMS, eTMF, RDC, IVRS, networks and infrastructures

Premier Research - 15 months ago - save job - block
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