Within the team "Toxicology Outsourcing" you will fulfill the role of Study Monitor and coordinator for toxicity studies outsourced from Roche to Contract Research Organisations (CROs).
In this position you will:
- Ensure as far as possible the technical and scientific quality of outsourced studies
- Have good and open communication to Toxicology Project Leaders and other scientists involved in outsourced studies
- Order test item or formulations and ensuring that relevant information is provided to the Study Director at the CRO
- Review draft study plans (protocols) and amendments as necessary in cooperation with representatives of the appropriate functional areas and with the involved scientists and QA. Provide project toxicologist with a commented draft for review.
- Ensure scientific monitoring of the study, writing trip reports, developing of solutions for issues and initiate escalation of any issues as necessary
- Review draft versions of the study report in cooperation with representatives of the appropriate functional areas and with the involved scientists Provide project toxicologist with a commented draft for review and obtaining managerial approval.
- Deliver the final report and the study related documents to the CRO support group to ensure that the final report is processed in Roch Documentation Repository and that the study related documents are archived
- Complete the CRO evaluation form at the end of studies (after report finalization)
- Ensure that the records and materials from PI/CS at Roche Basel are archived as stated in the study plan and amendments