Project Specialist

ICON plc

Clinical Project Specialist at ICON supporting global project managers to deliver clinical studies. Focused on study management, budget oversight, and ensuring compliance with local regulations.

Posted 7/11/2026full-timeRemote • 🇷🇴 RomaniaJuniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial management, including oversight of eTMF completeness, budget management, and vendor coordination. Proficient in stakeholder communication and maintaining compliance with regulatory standards.

Highest-signal resume keywords

Clinical Trial ManagementETMF OversightBudget ManagementStakeholder CommunicationVendor Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ExperienceETMFCTMSBudget TrackingData CompletenessRegulatory ApprovalsProtocol DeviationsRisk ManagementStudy Plan DevelopmentAdvanced Excel

Soft Skills

Interpersonal SkillsCommunication Skills

Tools & Technologies

Microsoft OfficeExcelPowerPointWordOutlook

Industry Keywords

Life Science DegreeGlobal Project ManagementClinical ResearchStudy ConductRecruitment Progress

About the role

Key responsibilities & impact

Be a key member of the sponsor's Global Study Team contributing to delivering the clinical study to time, cost and quality
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
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
Data oversight, including oversight of eTMF completeness (eTMF setup, periodic reviews, following up on missing documents, Safety Reports Dissemination)
Maintain interactions and meetings with internal and external partners
Responsible for reviewing key clinical documents, leading development of study plans for external and internal use
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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

Competitive base salary and performance related incentives
Health and wellbeing programmes including medical, dental, and vision coverage where applicable
Retirement and pension plans
Life assurance and disability coverage
Employee assistance programmes and wellbeing resources
Learning and development opportunities through structured training and career pathways