Study Delivery Specialist
ICON Strategic Solutions
Job description
About the role
ICON plc is seeking a Study Delivery Specialist to support end‑to‑end clinical study operations across international, multi‑country trials. The role partners with Study Managers and cross‑functional teams to ensure studies are delivered efficiently, compliantly, and on schedule from start‑up through close‑out and archival.
Key responsibilities
- Support full clinical trial lifecycle activities from study start‑up through close‑out and archival.
- Maintain accuracy of study systems, databases, trackers, and project plans.
- Collaborate with internal teams, CROs, and vendors to ensure compliant and efficient study execution.
- Monitor study timelines, quality, risks, budgets, and operational performance metrics.
- Review and contribute to critical study documents, including protocols, informed consent forms, and operational plans.
- Lead development and maintenance of study management plans such as monitoring, risk management, communication, and vendor management plans.
- Manage vendor and CRO relationships, oversee deliverables, and ensure delegated activities are completed on time.
- Provide country‑level operational oversight including enrollment tracking, compliance, regulatory approvals, and issue management.
- Coordinate study meetings, maintain documentation repositories, track action items, and support team communications.
- Oversee clinical supplies and investigational product distribution while identifying and mitigating operational risks.
- Ensure inspection readiness through effective eTMF oversight and document quality management.
- Track study budgets, expenses, reconciliations, and change orders, escalating discrepancies when needed.
- Participate in cross‑functional study teams and support adherence to company SOPs, regulations, and industry standards.
Required profile
- Previous global project delivery experience within clinical research (mandatory).
- Strong understanding of the clinical trial lifecycle and regulatory requirements.
- Ability to manage multiple vendors, CROs, and cross‑functional teams.
- Excellent organizational and risk‑management capabilities.
Required skills
- eTMF oversight
What we offer
- Competitive salary and benefits package.
- Health insurance options for you and your family.
- Annual leave entitlements.
- Retirement planning.
- Inclusive culture that rewards high performance.
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Published 1 month ago
Expires 3 weeks from now
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ICON Strategic Solutions
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