Country Associate Submissions Representative

This is a fully remote position, open to applicants in Italy.

📋 Description

• Execute tasks related to Site Activation processes

• Lead and manage intricate projects as a Regulatory & Start-Up Specialist

• Ensure compliance with quality standards and project deadlines

• Prepare and submit documentation to regulatory authorities

• Conduct feasibility studies, site identification, startup, and site activation tasks

• Review, monitor, and facilitate the approval and execution of documents

• Guide junior Clinical Study Associates (CSAs) and serve as a Subject Matter Expert (SME) on specific topics

⛳️ Requirements

• Bachelor of Science degree in Health Sciences or a related discipline

• 1 to 3 years of pertinent experience in clinical research

• Familiarity with EUCTR and CTIS submission processes

• Experience in negotiating Site Contracts within Italy

• Background in medical device submissions

• Comprehensive understanding of clinical systems and procedures

• Strong communication skills in the local language

• Ability to work autonomously and juggle multiple projects

• Knowledge of Good Clinical Practice (GCP)/International Council for Harmonisation (ICH) and relevant regulatory guidelines

🏝️ Benefits

• Health insurance

• Flexible working hours

• Opportunities for professional development

• Incentive programs

• Bonuses

• Additional forms of compensation