Clinical Trials Laboratory Associate

As a Clinical Trials Laboratory Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

You will be partnering with a pharmaceutical company committed to discovering and developing treatments that improve and save people´s lives. Working in this program you will feel challenged and supported to advance in your professional career while making a truly impact.

What you will be doing:

In this role you will be a part of the Human Biological Samples Management Central Team. As a Laboratory Study Associate (LSA) you will work in close collaboration with the Laboratory Study Managers (LSMs), the Central Laboratories Oversight team and Cell Mediated Immunity (CMI) Network Laboratories team, providing operational and administrative support for the delivery of the project and study laboratory activities.

The LSA also supports the overall management of the laboratory study budget.

Key Responsibilities:

• Provide support in the set-up of specific meetings with internal as well as external stakeholders (e.g., Operational Excellence Committee (OEC)-meetings with Third Parties, Operational meetings with Third Parties).
• Creation, review, maintenance and tracking of clinical trial documentation related to lab activities.
• Support the collection and storage of study specific documents that are required for the electronic Trial Master File (eTMF).
• Ensure set-up and maintenance of study related databases and tracking tools as required throughout the trial.
• Providing support in the set-up and pro-active follow-up of operational laboratory related activities (e.g. status on lab supplies, sample tracking).
• Ensuring quality check / double-check on specific procedures.
• Provide support to the study budget follow-up (e.g. Introduce shopping cart request, check central laboratory invoices versus study price list and actual service done, ask for credit note, highlight issues related to actual budget versus PO amount to Lab Study Manager).
• Co-ordinate all study archiving activities.
• Assistance in the preparation and support of audits and inspections.
• Act as Quality & EHS coach for team staff, including monitoring of external partners.
• Ensure appropriate documentation and tracking of Quality & EHS related activities.

You are:

• Graduate Degree in life sciences or equivalent experience
• Solid expertise in laboratory operations and quality systems
• Familiarity with basic finance and accounting principles in order to understand budget, invoices, cross-charges and expense reports.
• Excellent computer skills (Microsoft Office (Excel, Word, PowerPoint), SAP)
• Knowledge of ICH/GCP
• More than 3 years expertise in similar or related job
• Ability to work within global teams
• Time management skills, ability to set and manage priorities and multiple tasks
• Fluent in speaking and writing in English
• Excellent communication skills
• Detail-oriented
• Able to evolve and in a changing and challenging environment.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.