Clinical Trial Manager

hace 4 días

Madrid, Madrid, España Icon A tiempo completo
Job Summary

As a Country Start-Up Lead at Icon, you will be responsible for the performance and compliance of assigned protocols in a country, ensuring adherence to ICH/GCP and country regulations, client policies, and quality standards. This role requires strong budget/finance management skills, as well as the ability to oversee clinical trial country submissions and approvals.

Key Responsibilities

* Ownership of country and site budgets
* Development, negotiation, and completion of Clinical Trial Research Agreements (CTRA)
* Oversees and tracks clinical research-related payments
* Payment reconciliation at study close-out
* Oversees FCPA, DPS/OFAC, and maintenance of financial systems
* Financial forecasting in conjunction with other roles
* Executes and oversees clinical trial country submissions and approvals for assigned protocols
* Develops local language materials, including local language Informed Consents and translations
* Interacts with IRB/IEC and Regulatory Authority for assigned protocols
* Manages country deliverables, timelines, and results for assigned protocols to meet country commitments
* Responsible for quality and compliance in assigned protocols in country
* Contributes to the development of local SOPs
* Oversees CTAs as applicable

Requirements

* Collaborates closely with Headquarter to align country timelines for assigned protocols
* Provides support and oversight to local vendors as applicable
* Oversees and coordinates 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
* Enters and updates country information in clinical and finance systems
* Ownership of local regulatory and financial compliance

This role has a significant impact on how a country can deliver country-specific trial commitments and objectives, especially during study start-up.

If you are a motivated and detail-oriented professional with experience in clinical trial management, we encourage you to apply for this exciting opportunity.

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