Clinical Trial Manager

We are currently seeking a Clinical Trial Manager to join our diverse and dynamic team at ICON Plc. In this critical role, you will be responsible for overseeing the planning, execution, and successful completion of clinical trials, ensuring adherence to timelines, budgets, and regulatory guidelines. As a leader in our research department, you will collaborate with cross-functional teams, manage site relationships, and provide strategic guidance to drive the successful delivery of clinical trial outcomes.

What you will be doing

• Plan and manage all aspects of clinical trials, ensuring adherence to timelines, budget, and quality standards.
• Collaborate with cross-functional teams to establish and implement clinical trial protocols and procedures.
• Build and manage strong relationships with trial investigators and stakeholders.
• Ensure all trials are conducted in compliance with local, national, and international regulations and ethical guidelines.
• Problem-solve and make critical decisions regarding trial design, vendor selection, and risk management.
• Serve as the primary point of contact for the clinical aspects of designated projects and develop successful cross-functional relationships with internal and external stakeholders.
• Plan, schedule, and implement the clinical aspects of projects in line with contracts and budgets, including protocol implementation, amendments, deviation tracking, IP management, and investigator payments.
• Drive enrollment to meet contracted timelines.
• Monitor key clinical metrics such as Days on Site (DOS), Monitoring Visit Report (MVR), Follow-up Letters (FUL), Action Items (AI), and other quality metrics, ensuring they are met and issues are addressed.
• Oversee review and approval of visit reports, manage site issue escalation and resolution, and interact with Central Visit Report Approvers as needed.
• Ensure clinical data is entered into the ICON CTMS or other CTMS systems accurately and promptly.
• Contribute to the development and maintenance of clinical elements in cross-functional project plans.
• Work on multinational studies and potentially serve as a Global CTM if appropriate.
• Document clinical risks, develop mitigation strategies, and manage associated action plans, including escalation and resolution of issues.
• Develop and maintain operational plans for clinical deliverables such as CRF completion guidelines, Monitoring Plans, Recruitment Plans, and Clinical Training Plans.
• Maintain the Trial Master File (TMF) in accordance with SOPs and the File Master Plan (FMP), including quality checks and archiving.
• Complete close-out activities, including End of Trial notifications, payments, updates to CTMS, and finalization of visit reports and action items.
• Lead or participate in clinical team meetings, ensuring timely communication of study progress and issues.
• Implement quality control activities, monitor quality metrics, and ensure compliance.
• Maintain confidentiality of sensitive information.
• Participate in business development activities such as bid defense meetings.
• Support individual project management tasks under supervision if required.

You are :

• University degree in medicine, science, or equivalent experience.
• Proven ability to drive clinical study deliverables.
• Subject matter expertise in the relevant therapeutic area.
• Prior monitoring and CTM experience required.
• Willingness to travel up to 20%.
• Goal-oriented, independent worker with proactive issue resolution skills.
• Detail-oriented with multitasking ability.
• Proficient in Veeva Vault and Microsoft Office applications.
• Good interpersonal skills and comfortable with ambiguity.

What ICON can offer you :

Our success depends on our people. We prioritize building a diverse culture that rewards high performance and nurtures talent.

In addition to a competitive salary, ICON offers various benefits focused on well-being and work-life balance, including:

• Annual leave entitlements
• Health insurance options
• Retirement planning options
• Global Employee Assistance Programme (TELUS Health)
• Life assurance
• Optional country-specific benefits such as childcare vouchers, gym discounts, and travel passes

Visit our careers website to learn more about working at ICON. We are committed to inclusion and diversity, providing an accessible environment for all candidates. We consider all qualified applicants without discrimination. If you need accommodations during the application process or to perform the role, please inform us.

We encourage you to apply even if you do not meet all listed requirements—your potential and enthusiasm are valued at ICON.