ICON plc logo
ICON plc

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

Project Specialist

GeneralGeneralFull TimeRemoteJuniorTeam 10,001+Since 1990H1B No SponsorCompany SiteLinkedIn

Location

Romania

Posted

3 days ago

Salary

0

Seniority

Junior

Bachelor Degree1 yr expEnglish

Job Description

Project Specialist

ICON plc

• 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.

Job Requirements

  • 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

  • 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

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