Biosample Coordinator
vor 10 Stunden
**_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
**Biosample Coordinator**
As Biosample Coordinator, you will contribute to the development of new therapeutics through planning and coordinating the operations and logistics necessary to execute the testing, analysis, and
storage of biological samples by third parties, for clinical trials and translational projects in
compliance with relevant regulations
**Your responsibilities will be but not limited to**:
- Work in close collaboration with our Translational Medicine functions to manage sample tracking, receiving, and storage processes for clinical and translational projects
- Support clinical study activities in the preparation and review of study-related documents (such as ICF, CRF, laboratory manual, DTS, etc.)
- Interface with laboratory personnel, sample processing vendors, and other vendors (e.g. vendor for long term storage) as needed to ensure proper shipment of samples, respond to issues as needed, and to ensure study objectives are met
- May contribute to the assessment of site and lab feasibility for biological sample collection, handling and storage
- Be responsible for the development and maintenance of a biorepository database for human and non-human biological samples
- Ensure biosample process consistency across clinical studies within their respective projects and manage sample logistics from patient to data, in compliance with GXPs.
- Participates in process improvement projects (SOPs, work instructions, training materials) in collaboration with QA and clinical study teams
- Forecasts the biosample operational costs and review contracts and invoices
**Requirements**:
- Bachelor or Master Degree in Life sciences
- At Least 2-3 years of experience working with Biosample Management & Coordination in Clinical Trials, working in collaboration with a Central Lab, CRO and Long term storage vendors
- First experience of assessing site and laboratory feasibility for biological sample collection is a plus
- Good understanding of overall Clinical Trial Operations and Translational Medicine
- Strong knowledge of GCP, GCLP and ICH guidelines, and animal welfare regulations
- Strong communication skills in English, you are able to translate the complex matter and Central Lab technical requirements to internal team and stakeholders
- Ability to foster a collaborative team environment and to work effectively with others in a fast-paced matrix organization
- Team spirit and strong service orientation
- Strong organizational skills with ability to manage stress, pressure and deadlines
**Benefits**
- International, highly dynamic environment with a long term vision.
- Cross-functional collaboration at the forefront of the most advanced scientific developments in oncology and anti-bacterial industry
- Exposure to a wide variety of areas and functions within clinical development and the pharmaceutical industry
- Participation in a company where innovation, people and entrepreneurship are the fundamental keys to 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._
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Biosample Coordinator
vor 1 Tag
Lausanne, Schweiz Debiopharm VollzeitDescription 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...