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Clinical Trial Manager
hace 2 meses
**Job Summary**
At Icon Plc, we are seeking a highly skilled and experienced Clinical Trial Manager - Country Lead to join our team. As a key member of our clinical operations team, you will be responsible for leading the country-level clinical trial management activities for assigned protocols.
**Key Responsibilities**
- Ownership of country and site budgets, ensuring alignment with company financial goals and objectives.
- Development, negotiation, and completion of Clinical Trial Research Agreements (CTRA) with local vendors and partners.
- Oversee and track clinical research-related payments, ensuring timely and accurate reimbursement.
- Payment reconciliation at study close-out, ensuring financial accuracy and compliance.
- Oversee FCPA, DPS/OFAC, and maintenance of financial systems, ensuring regulatory compliance.
- Financial forecasting in conjunction with other roles, providing strategic insights for business growth.
- Execute and oversee clinical trial country submissions and approvals for assigned protocols, ensuring timely and compliant delivery.
- Develop local language materials, including informed consents and translations, to support country-level clinical trials.
- Interact with IRB/IEC and Regulatory Authority for assigned protocols, ensuring compliance and regulatory adherence.
- Manage country deliverables, timelines, and results for assigned protocols, meeting country commitments and objectives.
- Responsible for quality and compliance in assigned protocols in country, ensuring adherence to company standards and regulations.
- Contribute to the development of local SOPs, ensuring consistency and compliance across country operations.
- Oversee CTAs as applicable, ensuring timely and compliant delivery.
- Coordinate and liaise with CTM, CTA, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs, and local milestones.
- Collaborate closely with Headquarters to align country timelines for assigned protocols, ensuring seamless integration and coordination.
- Provide support and oversight to local vendors as applicable, ensuring compliance and regulatory adherence.
- Oversee and coordinate local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management.
- Enter and update country information in clinical and finance systems, ensuring accuracy and compliance.
- Ownership of local regulatory and financial compliance, ensuring adherence to company standards and regulations.
**Requirements**
- Significant experience in clinical trial management, with a strong understanding of country-level operations and regulatory requirements.
- Proven track record of leading country-level clinical trial management activities, with a focus on quality, compliance, and financial management.
- Excellent communication and interpersonal skills, with the ability to interact with local vendors, partners, and stakeholders.
- Strong analytical and problem-solving skills, with the ability to navigate complex clinical trial management issues.
- Ability to work in a fast-paced environment, with multiple priorities and deadlines.
