Clinical Trial Administrator II (Pharmaceuticals)

TL;DR

Clinical Trial Administrator II (Pharmaceuticals): Managing study documentation and electronic Trial Master Files (eTMF) for a global CRO with an accent on regulatory compliance and budget oversight. Focus on coordinating between sponsors and CROs, ensuring ICH-GCP adherence, and maintaining registration dossiers.

Location: Milan, Italy

Company

hirify.global is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, and medical device companies.

What you will do

• Prepare and assemble study documentation and submission packages for Regulatory Authorities and Ethics Committees.
• Manage electronic TMF (eTMF) set-up, maintenance, and reconciliation, ensuring filing completeness through quality checks.
• Support budget development and operations, including invoice verification and Investigator Fees reconciliation.
• Coordinate with CROs through RFP reviews, Kick-Off Meetings, and continuous status updates.
• Ensure trial compliance with SOPs and quality standards, collaborating on corrective and preventive actions.
• Assist the eCTD team in formatting documentation for electronic registration dossiers.

Requirements

• Bachelor's degree.
• Experience in clinical research or healthcare, specifically as a Clinical Trial Assistant.
• Working knowledge of international regulatory and ICH-GCP guidelines.
• Proven experience managing study budgets, documentation, and TMFs.
• Ability to work independently and establish high-trust environments with clients.

Culture & Benefits

• Access to career opportunities within a global CRO environment.
• Supportive culture with a strong focus on professional development and continuous training.
• Inclusive work environment celebrating diversity in gender, race, and beliefs.
• Stability provided by a company with over 28 years of industry experience.

Hiring process

• CV submission and initial screening.
• Phone interview as the first step for qualified candidates.