Project Specialist

Project Specialist - Remote - Poland

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.

We are looking for candidates to work in a role in study management supporting global project managers in EMEA, APAC and US.

In this role you will work remotely and be part of the sponsor’s global study team.

Responsibilities & Tasks

• Key member of the sponsor’s Global Study Team, contributing to delivering the clinical study on time, cost and quality, and ensuring inspection readiness by overseeing study e TMF completeness.
• Budget oversight – managing Task/Change Orders, expenses, tracking updates, checking consistency between systems and agreements and escalating issues to the Project Manager.
• Country oversight, acting as a primary point of contact, tracking 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, ensuring continued monitoring and timely delivery of activities delegated to third parties.
• Data oversight, including e TMF setup, periodic reviews, following up on missing documents, Safety Reports Dissemination, and ensuring all e TMF documents are complete and verified for quality.
• Maintaining interactions and meetings with internal and external partners.
• 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).
• Monitoring study conduct and progress, identifying, resolving and escalating risks/issues.
• 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 e TMF and CTMS.
• Fluent English.
• Very good mastery of Microsoft Office tools (Excel, Power Point, Word, Outlook).
• 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.

Benefits

Competitive salary packages and annual bonuses tied to performance.

Health‑related benefits for employees and families, competitive retirement plans, life assurance.

Additional benefits include

• Annual leave entitlements.
• Health insurance offerings tailored to individual needs.
• Retirement planning offerings to maximise savings.
• Global Employee Assistance Programme and TELUS Health support.
• Life assurance.
• Flexible country‑specific optional benefits such as childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments.
• Equal Opportunity Employer

ICON is an equal opportunity and inclusive employer and 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.

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