Site Activation Specialist – Remote Clinical Trials

Parexel; Sant Vicenç dels Horts; A distancia; EUR 55.000 - 75.000; Jornada completa

Descripción de la vacante

Parexel is seeking a Site Activation Partner to lead or support operational activities from start-up to close-out for assigned studies and sites, ensuring timelines and compliance with GCP and sponsor standards. The role involves initiating IIP, regulatory collaboration, and issue resolution.

The position requires 2+ years in clinical trials and site activation, knowledge of ICH/GCP and FDA regulations, and fluency in English and local language.

Formación

• Minimum 2 years in Clinical Trials environment and site activation.
• Knowledge of ICH/GCP, FDA and global and local country regulations.
• Fluency in English and local language.
• Experience in pharma or CRO is a plus.
• BS/BA or life sciences degree preferred.

Responsabilidades

• Initiate and coordinate activities and essential documents management towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for sites initiation
• Provide support to resolve issues or concerns and timely escalation of Site issues
• Manage and coordinate with other supporting roles to ensure timely site activation and operational activities
• Collaborate with in country regulatory group, and provide related/applicable site documents, as well as in countries where parallel submissions (Regulatory authority and ethics) are required
• Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines
• Identify and resolve investigator site issues

Conocimientos

Clinical trial experience

Site activation

Regulatory knowledge

English fluency

Local language fluency

Educación

Bachelor's degree in life sciences

Diploma or certificate

Descripción del empleo

Parexel is seeking a Site Activation Partner to lead or support operational activities from start-up to close-out for assigned studies and sites, ensuring timelines and compliance with GCP and sponsor standards. The role involves initiating IIP, regulatory collaboration, and issue resolution.

The position requires 2+ years in clinical trials and site activation, knowledge of ICH/GCP and FDA regulations, and fluency in English and local language.