Beschreibung
On behalf of our client in the Life Science industry, Harvey Nash is looking for a CTM Oncology for a 6 month project in Switzerland.
The role
- Writing of clinical protocols and related documents
- Lead the clinical trial protocol development process
- Contribute to the medical/scientific input given for the development of trial-related documents and processes
- Obtain approval from internal review boards
- ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures
- Lead the clinical trial data ongoing medical/scientific review, final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations
- Support to develop clinical outsourcing specifications to facilitate bid templates and selection of CROs; manage interface with CROs in cooperation with the Business Relationship Manager in the Contract Management Department
- Forecast trial resources needs (internal and external costs)
- Contribute to the development of clinical sections of regulatory documents like Investigators' Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions
Requirements
- 4 years experience as CTM
- Knowledge of international GCP, clinical trial design, statistics, regulatory processes and global clinical development processes
- Knowledge and experience with oncology and haematology is an advantage
- BSc/MSc in scientific related field or equivalent
- Fluent English required additional languages are an asset
Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred). For further details feel free to call me. Im looking forward to receiving your application.