At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.
As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a cooperative environment where your work contributes to the development of treatments that benefit patients worldwide.
We are seeking an experienced Clinical Trial Manager (CTM) to support clinical studies. The CTM will be responsible for end-to-end clinical trial management, with a strong focus on study start-up, regulatory submissions, site contracting, budget negotiations, vendor oversight, and study execution.
Key Responsibilities
Study Start-Up & Regulatory Management
• Lead country-level study start-up and site activation activities.
• Coordinate regulatory authority and IEC/IRB submissions and approvals.
• Respond to regulatory and ethics committee queries and ensure timely resolution.
• Prepare, review, and approve study documents, including country and site-specific ICFs.
• Ensure compliance with ICH-GCP, local regulations, and study requirements.
Site Contracts & Budget Management
• Lead Clinical Trial Agreement (CTA) review and negotiation activities.
• Manage investigator/site budget preparation and negotiations.
• Review and approve site invoices and payment requests.
• Track study finances and ensure budget adherence.
Clinical Trial Management
• Provide operational oversight of assigned clinical trials from start-up through close-out.
• Drive study timelines, quality, recruitment targets, and deliverables.
• Identify operational risks and implement mitigation strategies.
• Collaborate with cross-functional stakeholders to ensure successful study execution.
Vendor & Import/Export Management
• Manage external vendors supporting clinical trial delivery.
• Coordinate import/export license applications and approvals for clinical trial materials.
• Ensure compliance with local requirements for investigational product m