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
(1 year fixed term contract)
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.
- 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.
- University/College degree level or equivalent in a relevant discipline.
- Proven track record of 3-5 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.
If you fit this profile please go to this page to send your application.
For more information : www.debiopharm.com