Quality Manager and Monitor (m/f/d)
Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg
The Bernhard Nocht Institute for Tropical Medicine (www.bnitm.de) is the largest Research Institute for Tropical Medicine in Germany and is the National Reference Centre for Tropical Pathogens, a WHO Collaborating Centre and member of the Leibniz Research Association.
With immediate effect we are in search of a
Quality Manager and Monitor (m/f/d)
at the department of clinical research
Scope of work:
- Responsibility for a clinical trial quality management system
- Preparation of complex standard operating procedures (SOPs) and tools for clinical trial processes
- Internal monitoring at the department
- Monitoring of clinical trials at partner institutions
- Ensuring compliance with Good Clinical Practice (ICH-GCP)
- Ensuring compliance with quality management processes and requirements
- Ensuring compliance with regulatory and country-specific requirements
- Preparation and support during audits and inspections
- Support of clinical trial data management
- Development, review and validation of databases for clinical studies
- Database maintenance and query management
- Participation in the quality assurance of the EDC systems used
- Collaboration with international partners
- Relevant professional experience (at least 1 year) in the quality management of regulatory clinical trials or a comparable specialized field
- Very good knowledge of spoken and written English and German, additional language skills (preferably French) are an advantage
- ICH-GCP and AMG knowledge
- Ability and interest to familiarize yourself with new IT systems and areas of responsibility
- Work experience in and willingness to travel to sub-Saharan Africa
- Interest in medical affairs
- A high degree of reliability, accuracy, team spirit, organizational skills and a sense of responsibility
- Independent and timely management of tasks.
- Open-mindedness and communication skills, also in an intercultural team
- Resilience in challenging situations
- A fixed-term contract for 2 years full-time with the option of continued employment. The position is generally suitable for part-time work
- Remuneration according to TV-AVH (comparable to TVöD)
- An interesting and varied job in a modern research facility
- Integration in an open-minded, motivated, international team
- A central location at the Landungsbrücken, which is easily accessible by public transport
- 30 days holidays per year
- Flexible and family-friendly working hours
- Childcare allowance
- Subsidy for HVV-Profi Ticket
- Company pension
- Opportunities for further education and training
- Special conditions in selected sports and fitness clubs
We support our employees in achieving a work-life balance and promote the professional equality of women and men. We strive to assist women in their scientific career, increase the number of women in research and reduce under-representation in all areas and positions in general. Applicants with disabilities will be given preference when equally qualified.
As a member of the Diversity Charter, the largest diversity management network in Germany, we are also committed to making diversity an integral part of our institute culture. It is our goal to create a working environment that is free of prejudice.
Please send your application with the usual documents (cover letter, detailed CV, certificates) by 20.2.2022 preferably in electronic form via our application form.
If you have any questions regarding the application process or the selection procedure, please contact Anja Göttsche from the Human Resources Department (goettsche(at)bnitm.de, phone: 040/42818-314).
For further questions about the advertised position, Dr. Groger (groger(at)bnitm.de, phone: 040/42818-480) will be at your disposal.