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ICON plc

Clinical Trial Manager

Posted 2 hours ago
5-10 years experience
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AI Summary

The Clinical Trial Manager will oversee end-to-end clinical trial operations, including study start-up, regulatory submissions, and site budget negotiations. They are responsible for driving study timelines, ensuring quality compliance, and managing external vendors and stakeholders.

Clinical Trial Manager

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 collaborative 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 management.
Stakeholder Management
  • Act as a key point of contact for investigators, sites, vendors, and internal teams.
  • Participate in governance meetings and provide study updates to stakeholders.
  • Support inspection and audit readiness activities.

Required Experience

  • 8+ years of Clinical Research/Clinical Operations experience.
  • Strong experience in: Clinical Trial Management (CTM) Study Start-Up Activities Regulatory Submissions & Approvals CTA Negotiations Site Budget Negotiations IEC/IRB Query Management Site Invoice Review & Payment Approval Vendor Management Import/Export License Management Site Activation & Oversight

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.


Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.


Benefits may include:

  • 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

Benefits may vary depending on role and location.


Visit our careers site to read more about the benefits ICON offers.


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 here.


Are you a current ICON Employee? Please click here to apply

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