Clinical Trial Manager / Oncology, Germany (897223-MM)
- Experience Level
Our customer develops small molecule drugs for the treatment of Cancer. The product pipeline includes promising active ingredients in various stages of clinical development.
We are currently looking for an enthusiastic Clinical Trial Manager for a permanent position in South Germany. Home based possible – from 50% to 100%.
As a Clinical Trial Manager, your goal is to ensure that clinical trials are carried out properly and of high quality. You will work closely with internal functions (e.g. pharmacovigilance, regulatory affairs) and external bodies (e.g. contract research companies, ethics authorities and study centers).
- Independent planning and GCP-compliant implementation of international clinical studies (phase I-III) in oncology;
- Coordination of a cross-functional study team, possibly in cooperation with a CRO;
- Management of study implementation, including feasibility, center selection, recruitment, timelines, vendor management and trial master file;
- Review and / or creation of study documents such as study plan, patient information, submission documents, CRF, study manuals;
- Identification and optimization of processes to increase internal quality standards and effectiveness;
- Preparation of the data as well as participation in the creation of presentations and publications;
Qualifications and Experience:
- University Degree in Natural science (in the field of pharmacy, biology or a similar qualification);
- At least 3+ years of experience in the planning and implementation of international clinical studies (phase I-III) within pharmaceutical, biotechnology industry or at a CRO is required;
- Very good knowledge of the ICH-GCP guidelines and other applicable regulatory requirements;
- Experience in Oncology;
- Excellent communication skills (in English; German language fluency will be an advantage);
- Very good planning and organizational skills as well as an independent, precise and solution-oriented way of working;
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