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Project Manager

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ICON plc

Aug 28, 2024

  • Job
    Full-time
    Senior Level
  • Healthcare
  • Dublin
  • Quick Apply

AI generated summary

  • You need laboratory experience, LIMS configuration skills, strong IT knowledge, GXP data handling, quality management system experience, and familiarity with lab accreditation and document control.
  • You will lead planning, define project scope, manage compliance, develop risk mitigation, train staff, track deliverables, communicate progress, and ensure quality assurance.

Requirements

  • Laboratory experience (clinical / pharma / production)
  • Experience with automated laboratory equipment interfaced to a networked LIMS
  • Strong IT skills and knowledge
  • In depth experience of working with and configuration of a LIMS system
  • Experience in a laboratory or similar environment handling GXP data
  • Knowledge of laboratory equipment and associated software desirable
  • Knowledge of data integrity compliance advantageous
  • Knowledge of lab accreditation processes and standards
  • Experience of working with a quality management system including a robust CAPA process
  • Standard operating procedure creation including document control system desirable

Responsibilities

  • - Lead the planning and implementation of data integrity procedures and compliance working with a cross functional group within the organisation.
  • - Facilitate the definition of project scope, goals and deliverables
  • - Define project tasks and resource requirements.
  • - Develop full-scale cross-functional project plans.
  • - Plan and schedule project timelines
  • - Qualification of laboratory equipment and associated software
  • - Identify gaps in compliance across the laboratory in equipment and software qualification
  • - Develop and Manage Risk Mitigation processes when gaps identified
  • - Incorporate mitigation processes into standard operating procedures
  • - Train laboratory staff on new processes post qualification
  • - Track project deliverables using appropriate tools
  • - Provide direction and support to project team
  • - Communication of project progress to key stakeholders and senior management
  • - Quality assurance
  • - Constantly monitor and report on progress of the project to all stakeholders
  • - Present reports defining project progress, problems and solutions.
  • - Implement and manage project changes and interventions

FAQs

What is the duration of the Project Manager contract?

The contract for the Project Manager position is for 12 months.

What qualifications are preferred for this role?

Desired qualifications include laboratory experience in clinical, pharma, or production settings, strong IT skills, experience with LIMS systems, and knowledge of data integrity compliance.

Will I be required to train laboratory staff?

Yes, part of the role involves training laboratory staff on new processes post-qualification.

What types of projects will the Project Manager oversee?

The Project Manager will lead projects related to laboratory IT and data integrity procedures, including equipment qualification and compliance.

Is experience in a regulatory environment important for this role?

Yes, experience handling GXP data and working with quality management systems is advantageous for this position.

How does ICON support employee professional development?

ICON offers a continuous learning culture that challenges employees with engaging work, as well as a comprehensive total reward package for professional development.

What types of benefits does ICON provide?

ICON offers various benefits, including annual leave entitlements, health insurance, retirement planning, employee assistance programs, life assurance, and optional benefits tailored to employees’ needs.

Are there opportunities for career advancement at ICON?

Yes, ICON is committed to fostering a diverse culture that nurtures talent and rewards high performance, providing opportunities for career advancement.

How do I apply if I need reasonable accommodation?

If you need a reasonable accommodation due to a medical condition or disability, please let us know through the appropriate request form provided in the application process.

Is prior experience with laboratory equipment necessary for this position?

Yes, knowledge of laboratory equipment and associated software is desirable for the Project Manager role.

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.