Role Description
We are seeking a highly organized and detail-oriented Clinical Trial Submission Manager to join our team on a part-time, contract basis. This role is ideal for a seasoned regulatory professional looking for a flexible, high-impact position within the Swiss clinical research landscape.
- Location: Remote (Must be based in Switzerland).
- Commitment: Up to 14 hours per week (Flexible).
- Type: Freelance / Independent Contractor MUST have your own business registered in CH.
- Focus: Managing the end-to-end submission process for clinical trial applications (CTAs) in compliance with Swiss regulations.
Key responsibilities
- Submission Management: Lead the preparation, assembly, and submission of Clinical Trial Applications (CTAs) to Swissmedic and Ethics Committees via the BASEC portal.
- Lifecycle Maintenance: Manage the submission of substantial amendments, safety reports, and end-of-trial notifications.
- RFI Management: Coordinate and draft high-quality, timely responses to Questions (RfIs) from regulatory authorities and ethics committees.
- Compliance: Ensure all trial documentation adheres to the Swiss Human Research Act (HRA), Clinical Trials Ordinance (ClinO), and ICH-GCP guidelines.
- Liaison: Act as the primary point of contact for regulatory bodies to ensure smooth approval timelines.
Experience
- Proven Track Record: Extensive experience in Swiss clinical trial submissions is mandatory.
- Technical Proficiency: Hands-on experience and active registration with Swissmedic and the BASEC portal.
- Regulatory Expertise: In-depth knowledge of the Swiss regulatory environment (HRA, ClinO, ClinO-MD).
- Strategic Problem Solving: Demonstrated experience managing complex amendments and successfully navigating regulatory queries.
- Languages: Fluency in English and at least one official Swiss language (German or French) is highly preferred.
- Residency: Must be currently based in Switzerland with the legal right to work as a freelancer.
This is a specialized role offering significant autonomy. You will have the opportunity to manage critical regulatory milestones for innovative trials while maintaining a healthy work-life balance through a part-time, remote structure.