Clinical Research Manager (CRM)
My client is a young and successful biopharmaceutical company located in Germany, developing innovative therapies require a Clinical Research Manager
You will have the overall responsibility for our clinical studies (phase Ib, II, III), including scientific, regulatory, administrative and financial aspects. This implies the preparation and processing of national and international projects under consideration of the local laws, international guidelines (ICH GCP) and applicable SOPs. You will be key to communication within various teams within the company and with external partners to ensure continuous oversight on project budget, quality and timelines as well as the supervision of the project resources.
- Support in setting up strategies regarding future development and clinical research scenarios
- 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 evaluations and preparation of Clinical Study Reports
- Appropriate internal and external cooperation to assure consideration of all aspects of clinical development
- Preparation of regular status reports to the management
- Oversight on project timelines, deliverables, quality and budget
- Set-up and/or review of study core documents, e.g. study protocol, investigator’s brochure, patient informed consent documents etc.
- Handling of contract negotiations with third party providers like CROs, freelance CRAs, central laboratories, etc.
- University degree in medicine or natural/ life sciences
- Profound knowledge and experience in relevant legislation and international guidelines (ICH-GCP)
- Minimum 4,5 years of experience in project management of clinical trials
- In-depth knowledge of the indication Oncology
- Sound understanding of biostatistical parameters and evaluations
- Refined colloquial and correspondence skills in German (written and spoken)
- Fluent in English (written and spoken)
- Experience in usual software (Word, Excel, Power Point, MS Project)
- Ready to take over responsibility, pro-active way of working
- Able to motivate and lead a team/ used to work in a team
- Able to recognise problems and provide solutions
- Excellent organisational skills
Please contact Emma Hobbs +44 1483 397070 email@example.com to discuss this position in more detail.