Clinical Operations Lead - Regulatory & Budgets (Spain)

IQVIA LLC; Madrid; Presencial; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

IQVIA is seeking a Spanish-speaking professional to lead performance and compliance for assigned protocols in country, ensuring adherence to ICH/GCP and local regulations. You will oversee budgets, contracts, country submissions, and approvals, with a focus on site readiness and vendor oversight.

The role requires strong experience in regulatory affairs, contracts and budgets, plus digital and AI competencies to boost productivity.

Formación

• Experience in regulatory affairs and financial aspects of clinical trials.
• Ability to manage budgets, contracts and payments across country operations.
• Familiarity with CTAs/CTRAs and local SOPs is a plus.

Responsabilidades

• Own country budgets and payments oversight throughout the study lifecycle.
• Develop and finalize Clinical Trial Research Agreements (CTRA) and oversee CTRAs.
• Coordinate country submissions/approvals and local language materials (consents, translations).
• Interact with IRB/IEC and Regulatory Authorities for assigned protocols.
• Collaborate with project teams to meet country commitments and timelines.

Conocimientos

Regulatory

Contracts

Budgets

Digital skills

AI competencies

Digital tools

Payments

Descripción del empleo

IQVIA is seeking a Spanish-speaking professional to lead performance and compliance for assigned protocols in country, ensuring adherence to ICH/GCP and local regulations. You will oversee budgets, contracts, country submissions, and approvals, with a focus on site readiness and vendor oversight.

The role requires strong experience in regulatory affairs, contracts and budgets, plus digital and AI competencies to boost productivity.