T2207- Clinical Trial Associate

Description

Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Our unique “development only” business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.

For our Clinical Operations organization based at our Headquarters in Lausanne, we are looking for a

Clinical Trial Associate

As Clinical Trial Associate (CTA) you contribute to bringing new treatments to patients with unmet medical needs through deep involvement in setup, maintenance and closures activities for assigned studies (from Phase I to III) in Oncology or Infectives Diseases. You support the study team and the Clinical Trial Manager (CTM) in the creation, update, and distribution of study materials, tools and documents

**Your responsibilities will be but not limited to**:
Effectively support Clinical Trial Managers in daily operational activities related to clinical trials with external vendors (CRO) and internal stakeholders
Generate, finalize 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 Sharepoint under the responsibility of the CTM. Ensure a clear and consistent structure and filing method
File and review ClinOps-related study documents on the eTMF system (Veeva Vault TMF) under the responsibility of the CTM and ensure inspection readiness of the study 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
Coordinate issues resolution with CRO (i.e. timelines, tools, vendor’s issues )
Manage vendors under supervision of the CTM (e.g. attend to/lead all dedicated meetings, review/approve minutes, act as key point of contact for vendor, follow-up on timelines and budget)
Support in Study Plans writing (approval by CTM)
Collect, challenge and consolidate initial study budget at study set-up and then follow up on an ongoing basis, upon request and under supervision of the CTM
Assist the CTM in internal study progression/reporting
**Requirements**:
University/College degree level or equivalent in a relevant discipline
First 2-3 years of experience as Clinical Trial Associate or comparable operating experience in Pharma/CRO/healthcare
First experience in handling budget and invoicing is an asset
Strong understanding of drug development process and medical terminology
Experience in Management and filing of Trial Master File content (Veeva Vault Experience is a plus).
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
Ability to solve problems and to anticipate them
Ability and willingness to handle special projects
Demonstrate excellent written and verbal communication skills in English and French
Home office is possible with some office visits, as agreed with the line manager

**Benefits**:
Possibility to work from home with weekly visit in the office (Lausanne)
The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry and be exposed to many areas within clinical development and the pharmaceutical industry.
The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.

Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm.