Clinical Trial Associate
Job ID: 62446 Location:
Lachen, CH
Job Level: Professionals Job Category: Research and Development Employment Type: Permanent position Career Level:
Become part of a vital chain and contribute to our common goal of making people’s lives better. Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing medicines sourced from human plasma and human cell lines. We are a privately-owned company, where the warmth of family meets the scale of a global organisation.
Join us in shaping our vision to provide new health solutions advancing human life.
Your main tasks and responsibilities
1. Set up and maintenance of Trial Master Files and lnvestigator Site Files according to Octapharma SOPs
2. Assist the Clinical Team in preparing clinical trial documents
3. Prepare, distribute, file, and archive clinical documentation
4. Review study files periodically for accuracy and completeness
5. Assist in the organization of lnvestigator Meetings and participate
6. Perform administrative tasks to support team members with clinical trial execution, as required
7. Assists in development of SOPs
8. Assist the Clinical Team in preparation of audits or inspections
9. May act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation
10. Manage returning/archiving of study files
11. Assemble and review regulatory packages for trial-related submissions to RA and IRB/lECs in accordance with ICH-GCP, applicable regulations, company SOPs and check the documents for regulatory submissions
Your expertise and ideal skill set
12. Previous experience as CTA in international trials or similar experience in office management of international trials would be strongly preferred
13. Fluent in both written and spoken English; preferably also in German
14. Computer literacy
15. Proficient in Word, Excel and Powerpoint
16. Able to manage multiple and various tasks with positive attitude
17. Able to prioritize workload with attention to details and within timelines
18. Work in a team and independently
19. A flexible attitude with respect to work assignments
Your department - where you make an impact
20. The Clinical Research and Development (CRD) Lachen team works in the therapeutic areas of Haematology and Critical Care
21. The overall responsibility of the CRD Lachen department is to develop medicines that target complex and life-threatening conditions.
22. We specialize in clinical development at all stages for newly developed and already marketed products
23. The department consists of 11 team members, and you will support both of the therapeutic areas while working in close collaboration with the Business Units, Medical Affairs and Regulatory Affairs.
Thrive with us
24. You help save lives - Every day is meaningful as we produce life-saving medicines
25. Family values - Long-term perspective for employees and relationships
26. Be rewarded with market-related salary and benefits package
27. You will have a high level of influence where you can make a difference and leave your footprint
28. Work with skilled and fun colleagues in a relatively informal organization
29. Skills development - We offer various internal and external employee and leadership trainings, trainee programs and digital solutions
It´s in our blood
We live diversity and stand for equal opportunities as an employer! We therefore look forward to receiving your application - regardless of age, gender, origin, sexual orientation, and religion.
Please apply in English.
Do you have any questions? Then get in touch with your contact person.
Mrs. Claudia Vignau
Octapharma AG
Seidenstrasse 2, 8853 Lachen
T: +41 55 451 21 35
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About Octapharma
Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. We employ more than 11,000 people worldwide to support the treatment of patients in 120 countries with products across three therapeutic areas: Immunotherapy, Haematology and Critical Care. With seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany, and Sweden, Octapharma also operates over 195 plasma donation centres across Europe and the US. With four decades of experience, we are committed to advancing patient care worldwide.