Netzwerk der Koordinierungszentren Klinischer Studien (KKS-Netzwerk) is currently offering a position to act as European Correspondent for Germany in the European Clinical Research Infrastructure Network (ECRIN, www.ecrin.org), with temporary contract in the following professional category:
Role and Responsibilities:
This is a unique opportunity for a motivated individual who wishes to further develop his/her career in clinical research and his/her experience of multinational research projects. The ECRIN-ERIC European Correspondent for Germany plays a pivotal role in the coordination of the activities within the ECRIN-ERIC, strengthening the interaction of ECRIN-ERIC and the national network in Germany (Netzwerk der Koordinierungszentren Klinischer Studien, KKS-Netzwerk e. V.) in order to facilitate and support participation in European multinational collaborations and within the national network.
The main duties of the ECRIN-ERIC European Correspondent will include the following:
- Providing a key contact point in Germany for ECRIN-ERIC and the network of European Correspondents in other ECRIN countries.
- Participating, as part of the ECRIN-ERIC Management Office, in the development and maintenance of ECRIN Quality Assurance systems, and regulatory knowledge facilitating the activity of the national representatives in the ECRIN activities
- Providing advice and support to national investigators and sponsors wishing to develop European multinational studies through ECRIN, providing the key communication link with other ECRIN partners through the network of European Correspondents
- Providing support to foreign investigators and sponsors wishing to undertake clinical research studies in Germany ensuring that information relating to foreign studies are appropriately disseminated to national and international researchers.
- Provide leadership for ECRIN- adopted clinical projects carried out in Germany and participating in the management of multinational projects within the national network as well as in services provided by ECRIN as appropriate
- Ensure that specific pieces of project work under the ECRIN initiative are introduced and completed successfully, in line with planned timelines and contribute to the delivery of these projects
- Compiling and distributing regular communications about the progress of ECRIN projects and details of new initiatives to national network
- Ensure that ECRIN-ERIC activities and mission are communicated efficiently to other stakeholders in Germany, particularly the information should be timely distributed within the national partners ensuring that they have the opportunity to contribute to relevant initiatives on time
- Be required to work closely with other members of national network, research stakeholders and France regulatory authorities and any other relevant professional bodies/organisations. In addition, excellent external links will be required with ECRIN team (core group and other European correspondents in other countries)
- Maintain within the national network in Germany a thorough understanding of the current clinical research regulatory environment; develop and maintain a good appreciation of the regulatory environment in other EU members states, particularly in relation to the interpretation and implementation of EU clinical trial legislation
- Assist the country specific Training and Education Team in identifying training needs and requirements of local network staff and clinical trials unit staff in relation to multinational clinical trials and regulatory and governance issues, and contribute to the development and delivery of training programmes as appropriate.
- Undertake any ad hoc initiatives as required by the ECRIN-ERIC Management office.
- University degree in Health or Life Science (preferably including Project Management qualification or equivalent experience); doctorate desirable
- Extensive multinational clinical research experience and experience in clinical trial management
- Good working knowledge of the principles of ICH Good Clinical Practice, the EU Clinical Trials Directive and relevant national regulatory requirements for clinical research and clinical trials in particular.
- Desirable complementary knowledge of experimental design, statistics and data management.
- excellent organisation skills; ability to manage a range of different projects simultaneously
- willingness and ability to exercise leadership skills and the skills to manage projects effectively
- excellent communication skills; ability to interact positively with a wide range of professionals
- be effective team players
- be willing to work flexibly in a fast moving and dynamic environment
- ability to think imaginatively, a capacity to innovate
- Excellent written and spoken English (working language) as well as German
- Computer and software knowledge (Microsoft Word, Excel, PowerPoint, Outlook)
- Position located in Berlin with travels in Germany as appropriate, and to the ECRIN-ERIC management office located in Paris as well as within Europe
For the time being, the position is limited to a period of two years, with prolongation possible depending on project involvement. The salary is set according to German public service salary scale (TV-L) for similar positions and will depend on qualifications and experience.
The post is under hierarchical responsibility of ECRIN-ERIC Director General who is based in Paris at the ECRIN Management Office and under the functional responsibility of the Central Office of the KKS-Netzwerk e.V. (www.kks-netzwerk.de).
The KKS-Netzwerk e.V. is a cooperation of currently 19 Coordinating Centres for Clinical Trials / Clinical Trial Centres (Ger.: Koordinierungszentren für Klinische Studien – KKS / ZKS) at German university hospitals. The Centres function as scientific service providers and research partners, providing expertise in the preparation, implementation and management of clinical trials to sponsors and principal investigators.
The Central Office of the KKS-Netzwerk e.V. located in Berlin, Germany, hosts the ECRIN national Office for Germany, where the European Correspondent is based.
Please email your complete application documents as one pdf file including a letter of motivation and Curriculum Vitae (European format with photo) to attention of Dr. Linda Stöhr at firstname.lastname@example.org or via postal mail to Nationales ECRIN-Büro, Geschäftsstelle des KKS-Netzwerk e. V., Alt-Moabit 96, 10559 Berlin, Germany.