Project Manager - Laboratory IT and Data Integrity

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The Role:

Project Manager - Laboratory IT and Data Integrity, Contract (12 months)

• 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

Desirable attributes:

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.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.