Clinical Trial Associate

À propos de cette offre

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.

Clinical Trial Associate

Your main tasks and responsibilities

• Set up and maintenance of Trial Master Files and lnvestigator Site Files according to Octapharma SOPs
• Assist the Clinical Team in preparing clinical trial documents
• Prepare, distribute, file, and archive clinical documentation
• Review study files periodically for accuracy and completeness
• Assist in the organization of lnvestigator Meetings and participate
• Perform administrative tasks to support team members with clinical trial execution, as required
• Assists in development of SOPs
• Assist the Clinical Team in preparation of audits or inspections
• May act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation
• Manage returning/archiving of study files
• 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

• Previous experience as CTA in international trials or similar experience in office management of international trials would be strongly preferred
• Fluent in both written and spoken English; preferably also in German
• Computer literacy
• Proficient in Word, Excel and Powerpoint
• Able to manage multiple and various tasks with positive attitude
• Able to prioritize workload with attention to details and within timelines
• Work in a team and independently
• A flexible attitude with respect to work assignments

Your department - where you make an impact

• The Clinical Research and Development (CRD) Lachen team works in the therapeutic areas of Haematology and Critical Care
• The overall responsibility of the CRD Lachen department is to develop medicines that target complex and life-threatening conditions.
• We specialize in clinical development at all stages for newly developed and already marketed products
• 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

• You help save lives - Every day is meaningful as we produce life-saving medicines
• Family values - Long-term perspective for employees and relationships
• Be rewarded with market-related salary and benefits package
• You will have a high level of influence where you can make a difference and leave your footprint
• Work with skilled and fun colleagues in a relatively informal organization
• 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

Want to find out more about us?

 
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About Octapharma