As a Project Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

The Project Specialist provides project coordination and administrative support to Study Teams for a portfolio of assigned studies.  This support includes tracking a wide range of key operational activities and maintenance of essential study documentation, including updates to the electronic Trial Master File (eTMF) and various study trackers. This position will work with internal team members and with external vendors or research partners.  The position reports to the Associate Director (AD) or Director of Observational and Collaboration Studies and will work cross-functionally and collaboratively to support a variety of study activities as needed.

• Assist the Manager, Sr Manager, AD or Director in the day-to-day operational activities of assigned studies to ensure study objectives and timelines are met with quality, in compliance with applicable SOPs and regulatory guidelines
• Ensure updates are made for each assigned study in the study tracking system in collaboration with the study leads to ensure information is up to date and accurate
• Maintain study files (including eTMF and SharePoint folders, or similar), develop study processes, tracking spreadsheets/systems, and other utilized study or departmental systems
• Liaise with Clinical Biomarker Sample Management for the tracking and coordination of biomarker testing with 3^rd party labs, if applicable
• Collaborate with the cross-functional Study Team/Clinical Development Organization team and external study team members to ensure timely study-specific for assigned studies.  Or collaboration with external stakeholders to gain training and access to CRO/vendor systems required for client study teams (e.g. external TMF).
• Coordinate Study Team and departmental meetings, setting up and managing meeting invites, collaborating with team to create meeting agenda, taking minutes and finalizing/filing meeting minutes or meeting summaries as well as action items
• Assist with vendor / clinical site agreements, budgets and reconciliation / tracking of client study teams as well as the external vendors

You are:

• At least 2 years of experience in a clinical research or similar environment
• Bachelor’s degree in a science-based discipline preferred
• Basic understanding of drug development or observational research, including familiarity with Health Authorities and ICH GCP guidelines or Good Pharmacovigilance Practices, Good Pharmacoepidemiology Practices
• Proficiency in Smarthsheet, Veeva eTMF, Microsoft Office products, including MS Word, PowerPoint, Teams, and Excel.
• Good verbal and written communication skills
• Excellent organizational skills and attention to detail
• Willingness to learn, able to take direction and ability to manage multiple tasks with shifting priorities

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.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

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

At ICON, inclusion & belonging are fundamental to our culture and values. 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, colour, 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.