Medical Expert (Physician) (m/w/d) for Clinical Research required - part-time!
Vakzine Projekt Management GmbH (VPM) is a private company founded in 2002 to develop vaccines and biopharmaceuticals.
In recent years, VPM has successfully led the development of promising biopharmaceutical candidates for its clients in the pharmaceutical industry, academic research and small biotechnology companies, and brought these products from the pre-clinical phase to clinical phases I-III. Our services cover the entire value chain of product development, as VPM gained experience in all steps during the development of own products. We provide our professional advice and support in the following areas:
- Clinical Trial Sponsorship
- Regulatory Consultancy
- Translational Project Management
- Valuation & Due Diligence
- Organizational & Quality Management
VPM is sponsor of clinical trials according to § 40 AMG. In order to strengthen clinical research in Europe, Africa, India and Australia, we are looking for a physician in the function of a Medical Expert.
The position is to be filled on a part-time basis with immediate effect. Remuneration will be in accordance with industry standards.
- Medical consulting and assistance in the preparation of study documents such as Investigator's Brochure (IB), Clinical Trial Protocol (CTP), as well as Paediatric Investigation Plan (PIP)
- Implementation of clinical development plans and strategies
- Interaction with key opinion leaders/experts in relevant development areas of our product candidates
- Request and review of study-relevant information and medical correspondence
- Evaluation and follow-up of adverse drug effects and interactions and documentation of these in accordance with GCP guidelines
- Support in the preparation of standard operating procedures in collaboration with clinical project managers
- Performance of all activities in accordance with Good Practice (GxP), national and European laws and internal company quality standards
Who you are:
- University degree in Medicine, ideally with a doctorate
- Experience in clinical research
- If possible, training in clinical trials (e.g. "Principal Investigator training")
- Ideally, knowledge of ICH-GCP, as well as the applicable legal regulations in the European and German environment
- Ability to work in a team and enjoy working in cross-functional project groups
- Willingness to travel
- Very good communication skills, also in an intercultural environment
- Very good knowledge of English
- Confident handling of standard software
We offer you an interesting job in a dynamic and open-minded team. You can expect motivated colleagues, working in an open and intercultural environment, a flexible allocation of working hours, as well as continuous further training in a very good working atmosphere.
We look forward to receiving your application!