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 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 prevention, IP management, and investigator payments.
* Drive enrollment according to 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 to ensure compliance.
* Oversee review and approval of visit reports, manage site issues, and escalate as appropriate.
* Ensure timely and accurate entry of clinical data into ICON CTMS or other systems.
* Contribute to the development and maintenance of clinical 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.
* Develop and maintain operational plans for clinical deliverables, such as CRF guidelines, Monitoring Plans, Recruitment Plans, and Training Plans.
* Maintain up-to-date core clinical documentation in the Trial Master File, including QC checks.
* Complete close-out activities, including EOT notifications, payments, CTMS updates, and final reports.
* Lead or participate in clinical team meetings and ensure effective communication of study progress and issues.
* Implement quality control activities and monitor quality metrics.
* Maintain confidentiality of information.
* Participate in business development activities, such as bid defense meetings.
* Perform 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, proactive, and able to work independently.
* Problem solver with attention to detail.
* Capable of managing multiple tasks and meeting deadlines.
* Proficient with Veeva Vault and Microsoft Office applications.
* Good interpersonal skills and comfortable with ambiguity.
What ICON can offer you :
Our success depends on the quality of 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 through TELUS Health
* Life assurance
* Optional benefits such as childcare vouchers, gym memberships, and more.
Visit our careers website to learn more about working at ICON. ICON is committed to inclusion and belonging, providing an environment free of discrimination and harassment. All qualified applicants will receive equal consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. If you need accommodation during the application process due to a medical condition or disability, please let us know.
We encourage you to apply even if you do not meet all listed requirements; you might be the right fit for this or other roles at ICON.
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