Portugal Regulatory & Site Activation Specialist

IQVIA; Oeiras; Presencial; EUR 40 000 - 65 000; Tempo integral

Resumo da oferta

IQVIA Portugal seeks a Regulatory and Start Up Specialist to manage country-level Site Activation tasks and EC/RA submissions in compliance with local and international regulations. Fluency in Portuguese is required and you will collaborate with SAMs, project management, and sponsors to ensure timely documentation and regulatory milestones.

You will oversee regulatory documents, maintain systems for tracking and reporting, and provide local expertise during project planning and timelines.

Qualificações

• Bachelor’s Degree in life sciences or a related field.
• In-depth knowledge of clinical systems, procedures, and corporate standards.
• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
• Knowledge of applicable regulatory requirements, including local regulations, SOPs and company’s Corporate Standards.

Responsabilidades

• Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
• Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
• Perform start up and site activation activities according to applicable regulations, SOPs and work instructions.
• Distribute completed documents to sites and internal project team members.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
• Review and provide feedback to management on site performance metrics.

Formação académica

Bachelor’s Degree in life sciences or a related field

Descrição da oferta de emprego

IQVIA Portugal seeks a Regulatory and Start Up Specialist to manage country-level Site Activation tasks and EC/RA submissions in compliance with local and international regulations. Fluency in Portuguese is required and you will collaborate with SAMs, project management, and sponsors to ensure timely documentation and regulatory milestones.

You will oversee regulatory documents, maintain systems for tracking and reporting, and provide local expertise during project planning and timelines.