Beschreibung
On behalf of one major client in the Pharma industry, Harvey Nash is currently looking for a Expert Clinical Manager (Oncology Clinical Development) for a project in Basel.
Project scope
Responsible for all operational aspects of 1 or more OGD clinical trial(s) under the leadership of Clinical Trial Head (CTH). Support all scientific aspects of clinical trial(s) Project tasks
Ensure all operational trial deliverables are met according to timelines, budget, operational procedures and quality standards Provide input and contribute to the development of protocols and related documents, in the ongoing scientific review of clinical data, and in trial data analysis, reporting and publishing. Prepare training materials and presentations related to the planning and conduct of the trial. Prepare clinical outsourcing specifications. Responsible for management of Contract Research Organizations and ensure adherence to scope of work within timelines and budget. Contribute to program level activities (eg, tracking of OGD program-related publications, development of clinical sections of regulatory documents like Investigators' Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions). Manage interactions with Oncology Development Operations and other relevant functions including Drug Supply Management and local medical organizations Accountable for accuracy of trial information in all trial databases and tracking systems Contribute to program level activities (eg, tracking of OGD program-related publications, development of clinical sections of regulatory documents like Investigators' Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions) Reports on region performance status (trial, monitoring and budget status) Experience
Advanced degree or equivalent education/degree in life science/healthcare required accompanied with = 2 years experience in clinical research. Bachelor degree or equivalent education/degree in life science/healthcare required if accompanied with = 4 years experience in clinical. Additional information:
Start Date: ASAP End Date: 31.01.14 Location: BASEL Interested?
Then please send your complete CV (word documents preferred) or contact me directly
I am looking forward to receiving your application
