Debiopharm Group™ is a Swiss-based global biopharmaceutical group of five companies active in the development and manufacture of drugs and diagnostics tools. Debiopharm focuses on developing prescription drugs that target unmet medical needs. The group in-licenses and develops promising drug candidates. The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide.
For our Clinical Research & Development department based in Lausanne we are looking for a:
Clinical Trial Associate Intern
(6 months temporary contract)
During this internship, you will actively support the Clinical Trial Manager (CTM) and Clinical Trial Associate (CTA) in daily operational activities and specifically in eTMF related activities, manage study documentation and prepare internal/external Trial Master File (TMF) audits.
Your main responsibilities
- File and archive all study documents on the eTMF platform under the responsibility of the CTM and ensure inspection readiness of the TMF.
- Actively participate in clinical operations initiatives to reach increased quality, productivity and study management efficiency
- Effectively support Clinical Trial Managers in daily operational activities related to clinical trials with external vendors (CRO) and internal stakeholders
- Update and/or track study reporting tools
- May Generate, finalize and distribute study team agenda and meeting minutes in a timely manner. Act as a support to the CTM for meeting preparation.
- May Follow up of study budget, preparation and update of purchase orders including management of study invoices
- 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.
- Basic knowledge and/or experience regarding Clinical Trial Management/Monitoring/Setup and GCP/ICH requirements as well as drug development process and medical terminology.
- Experience of Veeva Vault eTMF is a plus
- Curiosity and enthousiam
- Excellent spoken and written English and French.
- Team spirit and strong customer service orientation.
- 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.
- Become part of our team, gain hands-on experience and insight into the pharmaceutical industry by joining our traineeship program.
- We will give you the opportunity to « put your foot in the stirrup » and 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