Medical Manager/ Clinical Research Physician (Investigator)/ Medical Advisor/ Emergency doctor/ Resident internal Medicine
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- 04275 Leipzig
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- de | en
- 20.01.2023
Kurzvorstellung
Qualifikationen
Projekt‐ & Berufserfahrung
5/2022 – offen
Tätigkeitsbeschreibung
As CMCR-Germany, we advise and support clinical trial sites as well as pharmaceutical companies or CROs in the planning and implementation of clinical studies.
Furthermore, we offer training courses on various topics in the broad area of clinical trials.
It is our concern to lay the foundation for more valid and higher quality data through better cooperation based on a mutual understanding of sites, sponsors and CROs.
Klinische Studie
5/2021 – 4/2022
Tätigkeitsbeschreibung
- Planning and implementation of phase I-IV clinical trials including data collection, sampling and documentation in English
- Carrying out study visits
- Assessment of clinical safety with appropriate documentation
- Acquisition of study participants
- Counseling and medical care for study participants
- Development of an interdisciplinary network with clinics and resident doctors to exchange information on clinical studies
- Lectures to present clinical studies according to your indications
- Project management of study implementation with satellite centers
- Team management including training, induction of new colleagues and supervision of the study coordinators
- Preparation and monitoring of audits
- Further training in the area of Basic Live Support
- Exchange with the regulatory institutions BfArM and ethics committees including submission of study-specific documents
- Quality management including implementation and training of SOPs, implementation of the GDPR in the work processes
Klinische Studie
11/2019 – 6/2021
Tätigkeitsbeschreibung
In the Oncology Clinic I gained experience in diagnostics and treatment of cancer patients of various entities. Furthermore, I looked after our patients during their outpatient chemotherapy, treated unwanted side effects and acted as an advisor in relation to nutritional medicine in cancer.
In addition, our clinic was involved in conducting several clinical studies. As a subinvestigator, I conducted study visits and was and was responsible for patient safety.
Klinische Studie
6/2017 – 10/2019
Tätigkeitsbeschreibung
After my foray into anesthesia and intensive care, I returned to the Gastroenterology and Hepatology Clinic. Here I continued my residency training in internal medicine.
As an investigator, I was once again responsible for the implementation of clinical studies. In addition, I use the contacts I have made in surgery to establish an interdisciplinary network to improve patient acquisition. Furthermore, my expertise expanded to include transplantation medicine. In the transplantation outpatient clinic, I cared for patients before and after liver transplantation as well as study patients who were participants in corresponding clinical studies.
Klinische Studie
12/2014 – 5/2017
Tätigkeitsbeschreibung
To broaden my medical horizon, I switched to the clinic for anesthesia and intensive care at the University Hospital in Leipzig for 2.5 years. I gained experience in anesthesiological procedures and in the treatment of intensive care patients. I was particularly interested in patients after organ transplantation and after tumor surgery interventions.
I also completed my expertise here for the additional qualification in emergency medicine. In addition, I worked as an anesthetist in the trauma room of the emergency room.
Medizin
5/2014 – 11/2014
Tätigkeitsbeschreibung
Under the direction of Prof. Th. Berg, I gained my first experience in the field of clinical studies. As a subinvestigator, I was responsible for patient acquisition in the hepatology outpatient clinic, conducting the study visits and evaluating the data collected with regard to patient safety.
The hepatitis C studies at that time and the associated establishment of the new therapy options were a great experience. This gave me the opportunity to work with big pharmaceutical companies such as AbbVie, GILEAD Sciences Inc., Bristol-Myers-Squibb and MSD.
I also started my residency in internal medicine here.
Klinische Studie
Zertifikate
Ausbildung
Leipzig
Universitätsklinikum Leipzig, Leipzig
Kneippärztebund, Bad Wörishofen
Universität Leipzig, Leipzig
Universität Leipzig, Leipzig
Dr. Frank-Gymnasium, Staßfurt
Über mich
Within the last 8 years I have accompanied the implementation of more than 100 clinical trials of various indications. By working with different CROs and sponsors, I was also able to gain a lot of experience in the regulatory areas. My particular concern is quality management in clinical studies, both on the part of the test centers and on the part of the pharmaceutical companies and CROs.
With my work, I would like to create better cooperation based on mutual understanding between study centers, pharmaceutical companies and CROs in the future.
Weitere Kenntnisse
- Fluent in German (mother tongue)
- Good in Englisch (Understanding: C1 – Speaking: B2 – Reading: C1)
- Strong knowledge of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines (GCP, AMG, MPG)
- Hands on knowledge of Good Documentation Practices
- Proven Skills in Site Management including management of site performance and patient recruitment
- Good IT skills (use of MS office, use of OSx based software, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices
- Strong ability to manage time and work independently
- Quality-driven in all managed activities (Quality Management, SOPs)
Persönliche Daten
- Deutsch (Muttersprache)
- Englisch (Fließend)
- Europäische Union
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