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, budgets, 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 clinical aspects of designated projects and develop successful cross-functional relationships with internal and external stakeholders.
* Plan, schedule, and implement clinical aspects of projects in line with contracts and budgets, including protocol implementation, amendments, deviation prevention, 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 targets are met.
* Oversee review and approval of visit reports, manage site issue escalation and resolution, and interact with Central Visit Report Approvers as needed.
* Ensure timely and accurate entry of clinical data into ICON CTMS or other CTMS systems.
* Contribute to the development and maintenance of clinical elements within 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 issue escalation and resolution.
* Develop and maintain operational plans for clinical deliverables such as CRF completion guidelines, Monitoring Plans, Recruitment Plans, and Clinical Training Plans.
* Maintain up-to-date core clinical portions of the Trial Master File (TMF) in accordance with SOPs and FMP, including QC checks of investigator site files.
* Complete all close-out activities, including EOT notifications, payments, TMF updates, visit report finalization, and action item resolution.
* Lead or participate in clinical team meetings and ensure effective communication of study progress and issues.
* Implement quality control activities, ensure compliance with quality measures, and monitor relevant metrics.
* Maintain confidentiality of sensitive information.
* Participate in business development activities such as bid defense meetings.
* Perform individual project management tasks under supervision as needed.
You are :
* University degree in medicine, science, or equivalent experience.
* Proven ability to drive clinical deliverables of a study.
* Subject matter expertise in the designated therapeutic area.
* Prior monitoring experience and experience as a CTM.
* Ability to travel up to 20%.
* Goal-oriented, self-starter capable of working independently.
* Proactive in issue identification and resolution.
* Detail-oriented with multitasking ability.
* Proficient with Veeva Vault and Microsoft Office applications.
* Good interpersonal skills.
* Comfortable with ambiguity and acting without having the full picture.
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
* Flexible 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 and equal opportunity employment. If you need accommodations during the application process, please let us know.
We encourage you to apply even if you do not meet all the listed requirements; you might still be the right fit for this or other roles at ICON.
#J-18808-Ljbffr