Global Clinical Trial Associate - 1 year Contract

Clinical OperationsLausanne, Vaud, SwitzerlandFull time

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Description

Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and bacterial infections in order to improving 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. Bridging the gap between disruptive discovery products and real-world patient reach, we 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.

Here: apply.workable.com/debiopharm-group-sa/

Debiopharm International S.A. identifies high-potential compounds for in-licensing, conducts clinical development and then selects large pharmaceutical commercialization partners to maximize patient access across the globe.

For our Clinical Operations Department based at our Headquater in Lausanne, and to support the department, we are looking for a

Global CLINICAL TRIAL ASSOCIATE - 1 year Contract

The Global Clinical Trial Associate (CTA) is involved in the set up and follow-up of international oncology clinical trials, in the management of global study documentation and actively supports the Clinical Research Associate (CRA) and Global Clinical Trial Manager (CTM) by creating, updating, distributing 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, 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 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


• Proven track record of 3-5 years of experience as Clinical Trial Associate 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).


• 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;• Working knowledge of Microsoft Word, Excel, PowerPoint and Outlook


• Technology-savvy in all Microsoft Office 365 applications


• Ability and willingness to handle special projects


• Demonstrate excellent written and verbal communication skills in English and French

Benefits

• An international and highly dynamic environment, with a long term vision.


• 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.

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