Description
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 Lab Analyst III, you will perform technical assignments and testing in the Laboratory Department.
Key Responsibilities:
- Conduct complex laboratory testing, analyses, and troubleshooting activities in accordance with established procedures, regulatory requirements, and quality standards, ensuring the accuracy, reliability, and integrity of study data.
- Review, interpret, and evaluate laboratory results and trends, providing detailed technical assessments and recommendations to support clinical research studies and operational objectives.
- Serve as a subject matter expert for assigned laboratory systems, methodologies, and instrumentation, providing technical guidance and support across the laboratory.
- Lead quality control, quality assurance, method validation, and equipment qualification activities, including investigation and resolution of deviations, out-of-specification results, and laboratory issues.
- Drive continuous improvement initiatives by identifying opportunities to optimize laboratory workflows, improve efficiency, enhance data quality, and strengthen compliance processes.
- Collaborate with cross-functional stakeholders, including Clinical Operations, Data Management, Quality Assurance, Project Management, and Sponsors, to support study execution and laboratory deliverables.
- Lead or support the implementation of new technologies, instrumentation, assays, and laboratory processes while ensuring appropriate validation and documentation requirements are met.
- Author, review, and approve laboratory documentation, including SOPs, work instructions, validation protocols, deviation reports, CAPAs, and technical reports.
- Mentor, train, and provide technical leadership to junior laboratory personnel, fostering development of laboratory skills, regulatory knowledge, and best practices.
- Support inspection readiness activities and participate in internal audits, sponsor audits, and regulatory inspections as required.
- May act as a lead analyst or laboratory coordinator for assigned studies, projects, or functional areas, ensuring timely completion of laboratory deliverables and adherence to study timelines.
Your Profile: You will bring advanced scientific laboratory experience along with demonstrated technical expertise, leadership capabilities, and a commitment to quality and compliance in a regulated environment.
Required Qualifications and Experience:
- Bachelor's degree in a relevant scientific discipline, Clinical Laboratory Science, Medical Technology, Biology, Chemistry, or a related healthcare field.
- Current Medical Technologist (MT/ASCP), Medical Laboratory Scientist (MLS/ASCP), or Medical Laboratory Technician (MLT/ASCP) certification through the American Society for Clinical Pathology (ASCP), maintained in good standing throughout employment.
- 5+ years of laboratory experience in a clinical research, diagnostic, pharmaceutical, biotechnology, healthcare, or other regulated laboratory environment.
- Advanced knowledge of laboratory methodologies, analytical techniques, instrumentation, regulatory requirements, and quality systems applicable to laboratory operations.
- Experience troubleshooting complex laboratory issues, validating laboratory processes, implementing corrective and preventive actions (CAPA), and supporting sponsor audits and regulatory inspections.
- Proficiency with laboratory information management systems (LIMS), laboratory software applications, and data analysis tools.
- Experience developing, reviewing, and maintaining laboratory documentation, including SOPs, validation records, and quality documentation.
- Demonstrated experience serving as a technical lead, study lead, subject matter expert, or mentor within a laboratory environment.
- Strong analytical, organizational, problem-solving, and project management skills, with the ability to manage competing priorities and drive continuous improvement initiatives.
- Excellent communication, collaboration, and interpersonal skills, including experience training, coaching, and mentoring laboratory staff.
- Working knowledge of applicable regulatory and quality standards, including GCP, GLP, GMP, CLIA, CAP, COLA, and other relevant industry requirements.
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