CK QLS

Clinical Trial Manager

📢 Job Title: Senior DRA Clinical Trial Manager

📍 Location: Allschwil, Switzerland

🕒 Work Schedule: Full-time (100%)

📅 Start Date: ASAP

📆 Duration: 12 months (Contract)

We are looking for a Senior Clinical Trial Manager, to join our clients dynamic team in Allschwil. If you're passionate about regulatory affairs and ready to make an impact in the clinical trial space, we want to hear from you.

Key Responsibilities: Clinical Trial Applications (CTAs):

• Provide regulatory input and guidance for clinical trials across Europe and internationally.
• Prepare, submit, and maintain CTAs according to current regulatory requirements.
• Liaise with internal teams and external service providers (ESPs) to gather and manage submission documents.
• Communicate with Health Authorities (HAs) and ensure all regulatory deadlines are met throughout the trial lifecycle.
• Maintain up-to-date tracking sheets and documentation for CTA submissions, amendments, End of Trial notifications, and Clinical Study Report (CSR) synopses.
• Ensure accurate filing in electronic and paper Trial Master Files (TMFs).

Clinical Trial Team (CTT) Involvement:

• Actively participate in CTT meetings, offering regulatory insights and guidance.
• Support CTT members with submission strategy, country timelines, and regulatory processes.
• Keep stakeholders informed of HA interactions and submission statuses.

Additional Responsibilities:

• Coordinate regulatory aspects of import/export license submissions for applicable countries.
• Contribute to the development and improvement of SOPs and internal processes.
• Share expertise, country-specific insights, and support onboarding/training of fellow DRA Clinical Trial Managers.

Your Profile:

• Minimum 2 years' experience as a DRA Clinical Trial Manager (within Viatris or a similar organization).
• Strong knowledge of clinical trial regulatory requirements, particularly in Europe.
• Exceptional organizational and communication skills.
• High attention to detail and the ability to prioritize under tight deadlines.
• A collaborative, team-oriented mindset with a customer-focused approach.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Fluent in English (written and spoken); knowledge of other European languages is a plus.

Our client is more than a pharmaceutical company—they are a global team driven by a shared purpose. Join a collaborative environment, where innovation is encouraged, and your expertise will contribute to life-changing therapies worldwide.

It is essential that applicants hold entitlement to work in Switzerland. Please quote job reference 129 471 in all correspondence.