Admission requirements

Prerequisite for participating in the distance learning course Clinical Trial Management is a completed university degree ideally in the natural sciences, engineering, medicine, or pharmacy.

The course is designed in such a way that in addition, a qualified professional experience following the first university degree of typically no less than one year is required.

For applicants with less than 210 credits, the Dean will determine additional modules that must be successfully completed before admission to the final exam.

For the course, solid mathematical-statistical knowledge as well as English language skills are required, allowing students to acquire study content in English.

It is advantageous to bring a private notebook computer when attending the final events.

Details

The further education Master's distance learning programme in Clinical Trial Management qualifies in the area of planning, conducting, and coordinating clinical trials for drug approval as well as the conformity assessment procedures for medical devices.

Students are taught the competency profiles for the entire complex clinical trial process. They also get to know the involved departments.

The Master's programme connects the particular aspect of clinical research with the necessary knowledge of drug approval and the conformity assessment procedures for medical devices.

The programme leads to the internationally recognised degree of Master of Science (M.Sc.) and bears the quality seal of the Accreditation Council.

The programme offers good career prospects especially for individuals with the following first university degrees: (Molecular) Biology, (Bio-)Chemistry, Medicine, (Bio-)Medical Engineering, Pharmacy, Healthcare Management, Public Health, Nursing, Bioinformatics, Biometrics, Statistics.

The fields of knowledge include:

Anatomy, Physiology, Pathophysiology, Pharmacology Drug Development, Pharma Law, Conformity Assessment Procedures for Medical Devices, (Advanced Studies on Pharmacovigilance as an elective subject) Informatics, Web Technologies, Clinical Data Management, (Advanced Studies on Data Protection and Security as an elective subject) Medical-Scientific Information and Documentation, Medical Writing, Methods of Quantitative Data Analysis, (Advanced Studies on Empirical Research Methods in Medical Biometry and Epidemiology as an elective subject) Health Economics, Project Management, Communication

The distance learning programme consists of four study plan semesters and a Master's semester (for the preparation of the written Master's thesis and the oral final examination).

The study is modular and designed for professionals, meaning it can be completed alongside work. It consists of 12 subject modules spread over four semesters, and the 13th module includes the thesis and examination. In the fourth semester, three elective modules are offered, of which one must be chosen. The distance learning materials are made available online on the Moodle learning platform at the beginning of each semester. Students work on assignment tasks, the successful completion of which is a prerequisite for participation in the face-to-face phase. The dates for the final events usually fall between mid-March and late September and last 3-4 days per semester. They take place in person on the campus of the university in Berlin. Each module includes 4 teaching units of 45 minutes and a 90-minute written exam during the final event. The module grades result from the evaluations of assignment tasks and written exams. Registration for the Master's exam requires successful completion of the 12 subject modules. Registration should take place within 2 years after completing the final subject module. For continuing education participants who only take individual modules: Successful completion of individual continuing education modules will be certified.

Facing elaborate admission processes, highest security requirements, cost pressures in healthcare markets, and societal demands on healthcare, Clinical Trial Managers have excellent employment opportunities in the growing health market. Employees with in-depth knowledge of the basics and processes of drug development and the conformity assessment of medical devices including the regulatory environment are needed in many areas.

The interdisciplinary Master's distance learning programme in Clinical Trial Management points towards this career potential.

Possible fields of work arise in the field of management of clinical research for drug approval and the development of medical devices, especially in the area of planning, conducting, and coordinating clinical trials:

In the Pharmaceutical Industry At Clinical Research Organizations In Biotechnology Companies In Medical Technology Companies In Medical Care Facilities At Authorities, Associations, and Healthcare Institutions