Clinical Project Specialist

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

Responsibilities & Tasks:

• In this role you will be a key member of the sponsor's Global Study Team contributing to delivering the clinical study to time, cost and quality, and ensuring inspection readiness by taking an oversight over study eTMF completeness
• You will work in collaboration with the Global Clinical Project Managers to provide end to end operational and administrative support for study delivery activities in your assigned trials.
• This is a fully remote role and you will be responsible to perform activities for one or several global projects (2-3).
• You will be responsible for setting up and maintaining systems and tracking tools that ensure quality, consistency and integration of study data, following up on discrepancies if needed. Granting access to new system users.
• Monitoring study conduct and progress, identifying, resolving and escalating risks/issues
• Responsible for reviewing key clinical documents, including the Protocol and Informed Consent Forms, and leading development of study plans (e.g. Monitoring Plan, Vendor Management Plan, Protocol Deviation Management Plan, Risk Management Plan,Communication Plan etc.) for external and internal use in assigned studies.
• Maintaining interactions and meetings with internal and external partners
• Data oversight, including oversight of eTMF completeness (eTMF setup, periodic reviews, following up on missing documents, Safety Reports Dissemination), and assure that all eTMF documents are complete and verified for quality.
• Vendor management and CRO oversight, acting as a primary point of contact, overseeing study-specific deliverables, ensuring continued monitoring and timely delivery of activities delegated to third parties.
• You will be responsible for country oversight, acting as a primary point of contact, tracking of recruitment progress, data completeness and compliance, overseeing local budgets, protocol deviations, risks, regulatory approvals and import license status
• Responsible for overseeing delivery of clinical supplies, investigational products and all study materials provided by the sponsor or external service providers
• Responsible for budget oversight – managing Task/Change Orders, expenses, tracking updates, checking consistency between systems and agreements and escalating issues to the Project Manager

Requirements:

• Graduate or Bachelor level with at least 1.5+ years of clinical trial experience
• A proven experience in clinical reserch global study management is required (Global CTA, Project Associate, Study Associate or Project Coordinator)
• Global administrative experience working with eTMF and CTMS
• Fluent English
• Good understanding of the principles of project planning & project management in clinical research
• Scientific background and knowledge of clinical trials (including ICH-GCP) is required.
• Ability to manage multiple competing priorities within various clinical trials with good planning, time management and prioritization skills
• Familiarity with basic finance and accounting principles in order to understand budget, invoices, cross-charges and expense reports
• Tools knowledge like Microsoft office (Excel, PowerPoint, Word, Outlook, etc.)

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:

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.

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.