Description
We are looking for a
Manager Clinical Research (m/f)
Reference: -en
Start: asap
Duration: 6 MM
Place: in Rhineland-Palatinate
Branch: Pharmazeutische Industrie
Your tasks:
- Support in setting up strategies regarding future development and clinical research scenarios, which includes summary of scientific information as well as intensive cooperation with external advisors and key opinion leaders for setting up clinical development plans and specific trial designs
- Substantial input with regard to interim analyses, data evaluation and preparation of clinical study reports
- Appropriate internal and external cooperation to assure consideration
- Clinical development
- Oversight on project timelines, deliverables, quality and budget and presentation to management
- Set-up and/or review of study core documents, e.g. study protocol, investigator’s brochure, patient informed consent documents etc.
- Involvement in contract negotiations with third party providers, e.g. CROs, freelance CRAs, central laboratories, etc.
Your qualifications
- University degree in medicine or natural/life sciences
- Profound knowledge and experience in relevant legislation and international guidelines (ICH-GCP)
- Experience in clinical research and in clinical trial management
- In-depth knowledge of the indication oncology and phase III
- Sound understanding of biostatistical parameters and evaluations is preferable
- Refined colloquial and correspondence skills in German (written and spoken) is of advantage
- Fluency in English (written and spoken)
- Excellent knowledge of usual software (Word, Excel, PowerPoint, MS Project)
- Readiness to take on responsibility, pro-active way of working and hands-on mentality
- Able and willing to take over trial management tasks
Skills:
- Clinical project manager