Clinical Research Operations Lead

hace 4 semanas


Zaragoza, Zaragoza, España Engineeringuk A tiempo completo

Key Responsibilities:

As a Clinical Research Operations Lead, you will be responsible for overseeing the performance and compliance of assigned protocols in a country, ensuring adherence to ICH/GCP and country regulations, client policies, and quality standards.

Key Deliverables:

  • 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 the country
  • Contributes to the development of local SOPs

Collaboration and Communication:

Collaborates closely with Headquarters to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable.

Requirements:

Requires strong leadership and communication skills, with the ability to influence investigators, external partners, and country operations to adhere to budget targets and agreed payment timelines.



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