Job Responsibilities:
1. Provide regulatory input and guidance for clinical trials, ensuring submissions to European and international Health Authorities (HAs).
2. Prepare, submit, and maintain Clinical Trial Applications (CTAs) in compliance with regulatory requirements.
3. Coordinate with internal teams and external service providers (ESPs) to gather necessary documents for submission.
4. Ensure trials run smoothly from a regulatory perspective, meeting timelines for submissions, responses to HA questions, and trial notifications.
5. Maintain tracking sheets for submission and approval dates, and manage documentation in the Trial Master File (TMF).
6. Attend Clinical Trial Team (CTT) meetings, offering regulatory updates and advice on submission processes.
7. Support the creation and update of Standard Operating Procedures (SOPs), and share lessons learned with the team.
8. Liaise on import/export licenses and contribute to team training.
Candidate Requirements:
1. Minimum 2 years of experience as a DRA Clinical Trial Manager or equivalent experience.
2. Strong organizational and communication skills.
3. Attention to detail and ability to prioritize tasks effectively.
4. Customer-oriented with excellent MS Office skills.
5. Fluent in English, additional European languages are a plus.
Job Title: Clinical Operations Manager
Location: Switzerland
Schedule: Full-time
Duration: 12 months
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