Preclinical Study Manager

Vor 2 Tagen


Schlieren, Schweiz CDR-Life AG Vollzeit

CDR-Life is a young and innovative biotech company based in Schlieren, Zurich where we develop novel immunotherapies against cancer based on our unique tumor-targeting technology. It is a dynamic mission-driven company with a highly collaborative approach. The Research Unit coordinates all preclinical activities necessary for regulatory submission to enable CDR-Life’s clinical development activities. For this, we are looking for an experienced:
**_
Preclinical Study Manager_**
- Coordinating all preclinical CRO activities_
The Preclinical Study Manager will work in a cross-functional manner with the pharmacology and translational research teams to support preclinical activities conducted by CROs. This person will be responsible for the operational activities of entire studies including CRO management, contracting, logistics and reporting.

**Key Responsibilities**
- Responsible for the overall coordination of preclinical studies performed with CROs.
- Accountable for all operational activities with CROs including selection, contracting, management, study logistics, and documentation.
- Monitor and supervise preclinical studies with CROs to ensure deliverables according to timelines.
- Follow-up internally and with CROs to ensure that study related action items are being addressed.
- Ensure creation, review, maintenance, distribution, and archiving of study-related documents.
- Coordinate logistics aspects of materials from study initiation to study closure.

**Qualifications**
- MSc or PhD degree in biological sciences, pharmacology, toxicology, or a related discipline.
- 3+ years’ experience in a biotech, pharmaceutical, or nonclinical CRO setting.
- Experience overseeing / managing preclinical studies at CROs or experience at a preclinical CRO overseeing studies for clients required.
- Working knowledge of GLP compliance and FDA / ICH guidelines relevant to preclinical development is an advantage.
- Experience with preclinical safety research is a plus.
- Good communication and organizational skills.
- Strong team player with desire to contribute in a highly dynamic, professional, and growing biotech team.


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