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Clinical Trial Manager
hace 2 meses
We are seeking a highly skilled Clinical Trial Manager to join our team at ICON. As a Clinical Trial Manager, you will be responsible for leading the start-up process for clinical trials in a country, ensuring compliance with ICH/GCP and country regulations, client policies, and quality standards.
Key Responsibilities- Develop and execute country budgets and financial plans.
- Negotiate and manage Clinical Trial Research Agreements (CTRA) with local partners.
- Oversee and track clinical research-related payments and ensure timely reconciliation at study close-out.
- Ensure compliance with FCPA, DPS/OFAC, and financial systems.
- Develop and implement financial forecasting and risk management plans.
- Lead the country start-up process, including clinical trial submissions and approvals.
- Develop and manage 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 country commitments.
- Ensure quality and compliance in assigned protocols in country.
- Contribute to the development of local SOPs.
- Oversee CTAs as applicable.
- Coordinate with CTM, CTA, CRA, and other stakeholders to ensure country deliverables are obtained.
- Collaborate with Headquarters to align country timelines for assigned protocols.
- Provide support and oversight to local vendors as applicable.
- Oversee local processes, including clinical and ancillary supplies management, importing and exporting requirements, and insurance process management.
- Enter and update country information in clinical and finance systems.
- Bachelor's Degree in Business Finance/Administration/Life Science or equivalent healthcare-related experience.
- 5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business.
- Expertise in core clinical systems, tools, and metrics.
- Excellent English skills.
- Strong coordination and organizational skills.
- Skilled knowledge of budget and contract negotiations, local regulatory environment, and submission and approval processes.
- Ability to indirectly influence investigators, vendors, external partners, and country managers to address and resolve issues.
- Ability to make decisions independently with limited oversight.
- Requires strong understanding of local regulatory environment.
- Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
At ICON, we offer a competitive salary, annual leave entitlements, health insurance, retirement planning, and a range of other benefits to support your well-being and career growth.
We are committed to diversity, inclusion, and belonging and strive to create a workplace that is free from discrimination and harassment.
If you are a motivated and experienced Clinical Trial Manager looking for a new challenge, please apply today.
