Site Activation Partner/Study Start Up Specialist - FSP

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

The Site Activation Partner is responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and sponsor standards. Other duties to include but not limited to:

• 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 where applicable
• 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

Experience required for this role:

• School diploma/certificate with equivalent combination of education, training and experience; BS/BA or bachelor’s degree in life sciences preferred
• Minimum 2 years relevant experience in Clinical Trials environment and clinical site activation.
• Experience working in the pharmaceutical industry/or CRO is an asset
• Knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations
• Must be fluent in Local language and in English. Multi-language capability is an asset

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EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.