Clinical Trial Manager

Job Title: Senior DRA Clinical Trial Manager
Location: Switzerland
Schedule: Full-time
Duration: 12 months

Job Responsibilities:

• Provide regulatory input and guidance for clinical trials, ensuring submissions to European and international Health Authorities (HAs).

• Prepare, submit, and maintain Clinical Trial Applications (CTAs) in compliance with regulatory requirements.

• Coordinate with internal teams and external service providers (ESPs) to gather necessary documents for submission.

• Ensure trials run smoothly from a regulatory perspective, meeting timelines for submissions, responses to HA questions, and trial notifications.

• Maintain tracking sheets for submission and approval dates, and manage documentation in the Trial Master File (TMF).

• Attend Clinical Trial Team (CTT) meetings, offering regulatory updates and advice on submission processes.

• Support the creation and update of Standard Operating Procedures (SOPs), and share lessons learned with the team.

• Liaise on import/export licenses and contribute to team training.

Candidate Requirements:

• Minimum 2 years of experience as a DRA Clinical Trial Manager or equivalent experience.

• Strong organizational and communication skills.

• Attention to detail and ability to prioritize tasks effectively.

• Customer-oriented with excellent MS Office skills.

• Fluent in English, additional European languages are a plus.