Country Study Start-Up Expert

CTI Clinical Trial and Consulting Services; Milano; Ibrido; EUR 40.000 - 55.000; Tempo pieno

Descrizione del lavoro

CTI Clinical Trial and Consulting Services in Milano, Italy, seeks a Regulatory Affairs Administrator to manage country-level submissions for Clinical Trials and RWE, coordinating with Ethics Committees and Competent Authorities.

The role requires 1-2 years in Clinical Research with regulatory exposure and fluency in Italian and English. You will collaborate with CTI Legal and Budget teams to ensure compliant start-up and study activities.

Competenze

• 1-2 years of experience in Clinical Research (pharmaceutical, site or CRO service) and regulatory in country.
• Associate’s or Bachelor’s Degree in allied health field or equivalent experience.
• Fluent in spoken and written Italian and English.

Mansioni

• Inform the regulatory team of changes in drug law, guidelines and submission requirements at country level.
• Review and prepare local submission documents and perform submissions to Ethics Committees and Competent Authorities.
• Identify Ethics Committees and Authorities needed for the study; manage pre-payments and adapt documents to local specifications.
• Serve as applicant for Clinical trials/RWE and be main point-of-contact for EC/CA and CTI specialists.
• Communicate with CTI regulatory teams regarding EC/CA outcomes and manage documentation in TMF systems.
• QC/QA of regulatory documents and reports; archiving and close-out activities as required.
• Oversee translation of regulatory documents when needed and support with site budget processes.

Conoscenze

Fluent Italian

Fluent English

Formazione

Associate’s or Bachelor’s Degree in allied health

Descrizione del lavoro

CTI Clinical Trial and Consulting Services in Milano, Italy, seeks a Regulatory Affairs Administrator to manage country-level submissions for Clinical Trials and RWE, coordinating with Ethics Committees and Competent Authorities.

The role requires 1-2 years in Clinical Research with regulatory exposure and fluency in Italian and English. You will collaborate with CTI Legal and Budget teams to ensure compliant start-up and study activities.