2 days ago

Clinical Trial Associate

Debiopharm International SA

  • Work region
  • Sector
  • Employment type
  • Position

Debiopharm Group™ (Debiopharm) is a Swiss-based biopharmaceutical group of four companies active in drug development, GMP manufacturing of proprietary drugs, diagnostics, and investments. Debiopharm International SA searches, evaluates and in-licenses promising drug candidates for development. Towards the end of the development process, the products are licensed out to pharmaceutical companies for world-wide marketing and sales. For our Clinical Operations Service, Clinical Research & Development Department based at our Headquater in Lausanne, we are looking for a:


 

Clinical Trial Associate

Debiopharm Group™ (Debiopharm) is a Swiss-based biopharmaceutical group of four companies active in drug development, GMP manufacturing of proprietary drugs, diagnostics, and investments. Debiopharm International SA searches, evaluates and in-licenses promising drug candidates for development. Towards the end of the development process, the products are licensed out to pharmaceutical companies for world-wide marketing and sales. For our Clinical Operations Service, Clinical Research & Development Department based at our Headquater in Lausanne, we are looking for a:


 

The Clinical Trial Associate (CTA) is involved in the set up and follow-up of the studies, in the management of study documentation and actively supports the Clinical Research Associate (CRA) and Clinical Trial Manager (CTM) by creating, updating, distributing study materials, tools and documents.


 


Your responsibilities



  • Effectively support Clinical Trial Managers in daily operational activities related to clinical trials with external vendors (CRO) and internal stakeholders;




  • Generate, finalise and distribute study team agenda and meeting minutes in a timely manner. Act as a support to the CTM for meeting preparation;




  • Collect, verify and upload documents into the eRoom (Sharepoint) under the responsibility of the CTM. Ensure a clear and consistent structure and filing method;




  • File and archive all study documents on the eTMF platform under the responsibility of the CTM and ensure inspection readiness of the TMF;




  • Follow up of study budget, preparation and update of purchase orders including management of study invoices;




  • Update and/or track study reporting tools (e.g. weekly follow-up chart, Export of the CRO reporting tool, CTMS.);




  • May create and distribute documents for study sites such as study binders. May prepare regulatory files for submission to Health Authorities and Ethics Committees;




  • May contribute to transversal activities such as ClinicalTrials.gov registrations, clinical trial insurances etc.



Your profile



  • University/College degree level or equivalent in a relevant discipline.




  • Proven track record of 5 years of experience as CTA or comparable operating experience in Pharma/CRO/healthcare with good knowledge of budget and invoicing requirement, as well as drug development process and medical terminology.




  • Experience in Management and filing of Trial Master File content (Veeva Vault Experience is a plus).




  • Excellent spoken and written English and French.




  • Customer orientation and team spirit, with ability to foster a collaborative team environment and to work effectively with others in a fast paced matrix organization;




  • Ability to communicate with cross-functional teams.




  • Strong organizational skills with ability to manage stress, pressure and deadlines.




  • Good to advanced computer skills with requirement of MS applications.


     



Debiopharm International can offer you:



  • An international and highly dynamic environment.




  • The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry.




  • The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.



CP 5911 /Chemin Messidor 5-7 1002 Lausanne