Project Specialist

Project Specialist / Study Delivery Specialist / SMA / Project Coordinator - Remote

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

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

• Responsible for budget oversight – managing Task/Change Orders, expenses, tracking updates, checking consistency between systems and agreements and escalating issues to the Project Manager

• 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

• 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. 

• 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.

• Maintaining interactions and meetings with internal and external partners

• 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.

• Monitoring study conduct and progress, identifying, resolving and escalating risks/issues 

• 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.

Your Profile:

• Life Science degree

• 1+ years of clinical trial experience within clinical research

• Experience in global project management/supporting global cross-functional teams at study level would be an advantage

• Experience working with eTMF and CTMS

• Fluent English

• Very good comprehension of Microsoft Office tools (Excel, PowerPoint, Word, Outlook, etc.).

• Knowledge of advanced Excel, timelines/budget tracking systems and clinical trial management systems is an asset.

• Excellent stakeholder management and communication skills (oral and written), outstanding interpersonal skills.

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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 maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

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, 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 or submit a request here

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.

Are you a current ICON Employee? Please click here to apply