Role Description
At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICONβs global expertise. 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:
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Study start-up
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Regulatory submissions
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Site contracting
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Budget negotiations
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Vendor oversight
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Study execution
Key Responsibilities
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Study Start-Up & Regulatory Management
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Lead country-level study start-up and site activation activities.
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Coordinate regulatory authority and IEC/IRB submissions and approvals.
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Respond to regulatory and ethics committee queries and ensure timely resolution.
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Prepare, review, and approve study documents, including country and site-specific ICFs.
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Ensure compliance with ICH-GCP, local regulations, and study requirements.
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Site Contracts & Budget Management
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Lead Clinical Trial Agreement (CTA) review and negotiation activities.
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Manage investigator/site budget preparation and negotiations.
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Review and approve site invoices and payment requests.
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Track study finances and ensure budget adherence.
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Clinical Trial Management
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Provide operational oversight of assigned clinical trials from start-up through close-out.
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Drive study timelines, quality, recruitment targets, and deliverables.
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Identify operational risks and implement mitigation strategies.
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Collaborate with cross-functional stakeholders to ensure successful study execution.
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Vendor & Import/Export Management
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Manage external vendors supporting clinical trial delivery.
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Coordinate import/export license applications and approvals for clinical trial materials.
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Ensure compliance with local requirements for investigational product management.
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Stakeholder Management
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Act as a key point of contact for investigators, sites, vendors, and internal teams.
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Participate in governance meetings and provide study updates to stakeholders.
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Support inspection and audit readiness activities.
Qualifications
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8+ years of Clinical Research/Clinical Operations experience.
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Strong experience in:
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Clinical Trial Management (CTM)
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Study Start-Up Activities
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Regulatory Submissions & Approvals
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CTA Negotiations
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Site Budget Negotiations
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IEC/IRB Query Management
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Site Invoice Review & Payment Approval
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Vendor Management
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Import/Export License Management
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Site Activation & Oversight
Benefits
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Competitive base salary and performance related incentives
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Health and wellbeing programmes including medical, dental, and vision coverage where applicable
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Retirement and pension plans
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Life assurance and disability coverage
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Employee assistance programmes and wellbeing resources
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Learning and development opportunities through structured training and career pathways
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Benefits may vary depending on role and location.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request.