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date title
26/03/09
referral award  not applied
  Toxicology Study Monitor/Outsourcing Coordinator
Roche (F. Hoffmann-La Roche AG)
Basel

Toxicology Study Monitor/Outsourcing Coordinator
The mission of the Outsourcing & Documentation section is to provide support within Non-Clinical Safety (Toxicology and DMPK) concerning the outsourcing of toxicology and bioanalytical studies, the reporting of internal and external studies, the shipment of API and formulations and the overall planning within Basel Non-Clinical Safety.

This is a newly created position with the aim to centralize the study monitoring/coordination from previously a number of individuals to one person. You will be responsible for the study monitoring and coordination of all outsourced toxicology studies from Roche Basel. The majority of studies will be general toxicitiy studies. Your main tasks will be the discussion and agreement on study design internally with Project Toxicologists and scientists from different disciplines based on provided study outlines, achieve agreement with CROs on technical and scientific aspects of studies, setting up draft and final protocols with CROs, control quality by monitoring studies at the CROs, resolution of issues, timely communication of all critical data to project toxicologist or area expert, review of draft report, manage organizational and financial study aspects in close interaction with Roche Procurement and with support from within the group, maintain overview on all planned and ongoing studies, tracking of timelines for all outsourced studies in existing system, involvement in general discussions with CROs to ensure Roche access to state of the art CRO services. You will be located in Basel, Switzerland and report directly to the Head Non-Clinical Safety Outsourcing & Documentation.
Qualifications: Bachelors Degree
Doctorate
Experience: 5 years +
Languages: English : Speak / Write Fluently
Job-Type: open-ended
Remuneration: unspecified
Permit Type: EU National
Region: Basel
You are a scientist with a Ph.D or masters degree in biology, veterinary medicine or other life sciences and you are an experienced/senior toxicologist who has worked within the pharmaceutical industry, experience of work at a CRO can be an advantage. You have worked for at least 3 years as Study Director and for at least 5 years as Study Monitor on general toxicity studies.
The following skill sets are required for this critical position within Non-Clinical Safety: Excellent communication skills, friendly and open personality, team player, well organized, pragmatic, goal oriented, focused, highly motivated, fluent English skills in speaking and writing (native speaker will be an advantage), willingness to travel frequently (also on short notice in case of issues).

Please apply online at http://careers.roche.com
Who to contact:
Contact HR: Dr. M. Ceroni, Phone: +41 61 687 34 58
Contact Line: M. Bopst, Phone: +41 61 687 43 37

At Roche, 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity, and on seeing each other’s differences as an advantage. To innovate healthcare, Roche has ambitious plans to keep learning and growing – and is seeking people who have the same goals for themselves.

The headquarters in Basel is one of Roche’s largest sites. It is home to the Corporate Executive Committee, the Pharmaceuticals and Diagnostics Divisions and the global business functions. Roche Basel also covers the entire business chain from research, development and production through to marketing. Over 8,000 people from more than 60 countries work at the site.

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