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Overview

The advanced distance learning master’s course in Clinical Trial Management qualifies students for the planning, implementation and coordination of clinical studies for the approval of medicinal products.

The students are taught the competence profiles for the entire complex clinical examination process. You will also get to know the departments involved.

The master’s degree combines the special aspect of clinical research with the necessary knowledge of drug and medical device approval.

The course leads to the internationally recognized Master of Science (M.Sc.) degree and bears the quality seal of the Accreditation Council (with qualification for higher service).

The degree offers biologists and natural scientists in particular good development opportunities.

 

PROGRAMME STRUCTURE

The areas of knowledge include in detail:

  • Anatomy, physiology, pathophysiology and pharmacology
  • Drug development and safety
  • ethics
  • Regulations
  • IT applications and IT systems in clinical research
  • Clinical data management and data protection
  • Medical and scientific information and documentation
  • Monitoring
  • Applied statistics / biometrics / epidemiology
  • Project Management (in English) 

 

module Module name Credits (credit points according to the European Credit Transfer System)
  1st semester 15th
M01 Drug development 5
M02 Anatomy and physiology 5
M03 Health economics and special business management aspects 5
     
  2 semesters 15th
M04 Biometrics / statistics 5
M05 Pathophysiology and pharmacology 5
M06 Computer applications in clinical research 5
     
  3rd semester 15th
M07 Project Management in Clinical Research (module in English) 5
M08 Computer systems for clinical research 5
M09 Medical scientific documentation 5
     
  4th semester 15th
M10 Monitoring 5
M11 Clinical data management 5
M12 Elective module:
a) Drug safety and ethics / regulations
b) Data security and data protection in medicine
c) Applied medical biometrics and epidemiology
5
     
  5th semester 30th
M13a Final examination (master's thesis) 25th
M13b Final exam (oral exam) 5
     
  Sum of all credits 90

 

ENTRY REQUIREMENTS

The prerequisite for taking part in the Clinical Trial Management distance learning course is a university degree , preferably with a biological / natural science background.

We recommend that you have a relevant professional experience of at least one year after completing your first university degree.

For applicants with fewer than 210 credits, the dean determines additional modules that must be successfully completed by the time they are admitted to the final examination.

For the course, solid mathematical and statistical knowledge as well as English skills are required, which allow the students to work on English-language course content. 

 

CAREER PROSPECTS

In view of the complex approval process, ethically justified highest safety requirements, the cost pressure in the health care markets and the demands of society on the health care system, clinical trial managers have excellent employment opportunities in the growth market of health.

The pharmaceutical industry and contract research institutes are increasingly looking for employees with in-depth knowledge of the fundamentals and process of drug development, including the regulatory environment such as the drug law and EU directives.

The interdisciplinary master’s distance learning course in Clinical Trial Management leads to this career potential.

The degree opens up a wide range of activities in the field of clinical research, in particular in the area of ??planning, conducting and coordinating clinical studies.


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