Project Specialist (Study Delivery) - Remote
icon · Bucharest
Job description
About the role
ICON, a global healthcare intelligence and clinical research organisation, is looking for a Project Specialist (also called Study Delivery Specialist, SMA or Project Coordinator) to join its global study management team. You will work remotely and support global project managers across EMEA, APAC and the US, acting as a key member of the sponsor's global study team.
Key responsibilities
- Budget oversight: manage task and change orders, track expenses, check consistency between systems and agreements, and escalate issues to the Project Manager.
- Act as primary point of contact for recruitment progress, data completeness and compliance, oversee local budgets, protocol deviations, risks, regulatory approvals and import licence status.
- Act as primary point of contact for vendors, oversee study-specific deliverables and ensure timely delivery of delegated activities.
- Oversight of eTMF completeness and maintain interactions and meetings with internal and external partners.
- Review key clinical documents such as the Protocol and Informed Consent Forms, and lead the development of study plans (Monitoring Plan, Vendor Management Plan, Protocol Deviation Management Plan, Risk Management Plan, Communication Plan).
- Monitor study conduct and progress, identify, resolve and escalate risks and issues.
- Set up and maintain systems and tracking tools for quality, consistency and integration of study data, follow up on discrepancies and grant access to new system users.
Required profile
- University degree.
- 1-2 years of clinical trial experience within clinical research.
- Availability to start within 1-2 months maximum.
- Experience supporting global cross-functional teams at study level is an advantage.
- Fluent English.
- Legal right to work in the country where the role is based.
Required skills
- Experience with eTMF and CTMS.
- Very good knowledge of Microsoft Office tools (Excel, PowerPoint, Word, Outlook).
- Advanced Excel, timeline and budget tracking systems, and clinical trial management systems are an asset.
- Excellent stakeholder management and communication skills.
What we offer
- 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 learning and development opportunities.
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Published 2 hours ago
Expires 1 month from now
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Bucharest