Overview
As a Clinical Trial Manager, you will join the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence. This role focuses on regulatory submissions, contract and budget negotiations, and reviewing reports at the site level. This is a local position within Ireland.
Responsibilities
* Ownership of country and site budgets, including development, negotiation, and completion of Clinical Trial Research Agreements (CTRAs).
* Oversee and track clinical research-related payments, including payment reconciliation at study closeout.
* Maintain compliance with FCPA, DPS/OFAC, and financial systems.
* Perform financial forecasting in collaboration with Sr. CTM and other roles.
* Execute and oversee clinical trial country submissions and approvals for assigned protocols.
* Develop local language materials, including informed consents and translations.
* Interact with IRB/IEC and Regulatory Authorities for assigned protocols.
* Manage country deliverables, timelines, and results to meet commitments.
* Ensure quality and compliance in assigned protocols.
* Contribute to the development of local SOPs.
* Oversee CTCs as applicable.
* Coordinate with CRM, CTC, CRA, Finance, and Legal to ensure deliverables for submissions, budgets, CTRAs, and milestones.
* Collaborate with headquarters to align country timelines.
* Support and oversee local vendors as applicable.
* Manage local processes, including supplies management, importing/exporting, destruction, filing, archiving, and insurance processes.
* Update country information in clinical and finance systems.
* Ensure regulatory and financial compliance locally.
* Impact country-specific trial delivery, especially during start-up.
* Influence investigators, partners, and operations, adhering to budgets and payment timelines.
* Work internally with GCTO functions and externally with vendors, sites, IRB/IECs, and regulatory authorities.
* Deliver clinical and financial contracts within fair market value through interaction with clinical teams.
Qualifications
You have:
* A degree in life sciences is preferred.
* Previous CRA experience is preferred.
* Experience negotiating contracts and budgets at the site level.
What ICON can offer you: Our success depends on our people. We prioritize building a diverse culture that rewards high performance and nurtures talent. Besides a competitive salary, ICON offers various benefits focused on well-being and work-life balance, including:
* Annual leave entitlements
* Health insurance options
* Retirement planning
* Global Employee Assistance Programme (TELUS Health)
* Life assurance
* Flexible benefits like childcare vouchers, bike schemes, gym discounts, travel passes, and health assessments
Visit our careers website for more: https://careers.iconplc.com/benefits
ICON values inclusion and belonging, providing an accessible environment for all candidates. We are committed to equal opportunity employment and reasonable accommodations for applicants with disabilities. If you need accommodations, please inform us via the provided link: https://careers.iconplc.com/reasonable-accommodations
If you're interested but unsure if you meet all requirements, we encourage you to apply. You might be exactly what we're looking for!
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