Project Leader, Clinical Research, Full-time w/ benefits, Portland, Oregon (OR)
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
Project Leader
The Project Leader will partner closely with the Senior Project Leader to support laboratory operations, equipment lifecycle management, compliance initiatives, and continuous improvement activities within our Portland, Oregon laboratory. This role serves as a key cross-functional resource, helping ensure laboratory equipment, documentation, and quality systems remain inspection and audit ready.
The Role
Key Responsibilities
- Support qualification, validation, and maintenance activities for laboratory equipment, including IQ/OQ/PQ documentation and execution.
- Assist with equipment lifecycle management, preventative maintenance coordination, calibration tracking, and troubleshooting activities.
- Draft, edit, review, and maintain controlled laboratory documents, procedures, forms, and records.
- Support audit and inspection readiness activities, including preparation for customer, regulatory, and internal audits.
- Assist with compliance initiatives related to CFR requirements, ISO standards, and applicable quality systems.
- Partner with laboratory teams to investigate equipment-related issues and support resolution of unexpected results or operational challenges.
- Coordinate and support WebEx and virtual equipment qualification activities as required.
- Work cross-functionally with laboratory operations, quality, validation, engineering, and project teams to ensure business priorities are achieved.
- Provide support across multiple initiatives and projects, contributing to operational excellence and continuous improvement efforts.
- Maintain accurate records and documentation to support compliance, traceability, and project tracking.
You Will Need
- Associate's degree in a scientific, technical, engineering, or related discipline required; bachelor's degree preferred.
- Previous experience supporting laboratory operations, equipment qualification/validation, quality systems, or regulated environments.
- Experience with equipment lifecycle activities, including installation, qualification, maintenance, and documentation preferred.
- Knowledge of cGMP, GLP, CFR requirements, ISO standards, and regulated laboratory environments preferred.
- Experience working with environmental monitoring systems (including REES is strongly preferred.)
- Strong technical writing, document control, and editing skills.
- Ability to manage multiple priorities and adapt quickly when operational issues arise.
- Strong collaboration and communication skills with the ability to work effectively across departments.
- Demonstrated attention to detail and commitment to quality and compliance.
#LI-HD1
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply