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 department based at our Headquarters in Lausanne, we are looking for a
Clinical Trial Associate
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. The CTA contributes to project team and study team goals.
CTA main responsibilities:
- Generate, finalise and distribute study team agenda and meeting minutes in a timely manner. Act as a support to the CTM for meeting preparation.
- File and archive all study documents on Veeva Vault (eTMF) under the responsibility of the CTM and ensure inspection readiness of the TMF.
- Verify vendor’s work order and create / update purchase orders accordingly, with confirmation from CTM.
- Follow up and discharge invoices according to the relevant purchase order on an ongoing basis, track payments to vendors and study sites and keep Accounts file up to date (financial agreements and payments).
- Ensure review of study budget (ProConcept Extract) under responsibility of the CTM.
- In case of short / unexpected absences of the CTM, systematically act as Backup and primary point of contact of the study by directing the action items to the most appropriate person.
- Contribute to the quality of all activities and key steps of the clinical study deliverables, and the delivery of the clinical study according to the ICH GCP and local applicable regulations, and in accordance with Debiopharm International’s SOPs/WPs.
- Update and/or track study reporting tools (e.g. weekly follow-up chart on-line, Export of the CRO reporting tool).
- University/College degree level or equivalent in a relevant discipline.
- Proven track record of at least 2 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.