Senior Clinical Research Manager (d/f/m)

DAS DEUTSCHE HERZZENTRUM DER CHARITÉ
The DHZC is located at the three clinical campuses of the Charité: the Virchow-Klinikum Campus, the Charité Mitte Campus and the Benjamin Franklin Campus. It comprises a total of eight clinics and institutes with around 2,500 employees and has around 470 beds. This will create one of the largest cardiac centres in Germany for treatments of all cardiovascular diseases patients of all ages.

Senior Clinical Research Manager (d/f/m)

Deutsches Herzzentrum der Charité (DHZC)

Charité Campus Virchow-Klinikum

Our requirement: In interdisciplinary, highly specialised "Heart Teams" we care for patients of all ages with cardiovascular diseases of all degrees of severity – around the clock. Our goal: Together we create interdisciplinary, holistic and sustainable cardiac medicine and lay the foundation for a world-leading quality of care in cardiovascular medicine. We stand up for: For the best care for patients and their families, for excellent research and teaching, for new therapeutic procedures and innovative technologies, for well-founded education and training, but also for satisfied employees and the talents of tomorrow. Your area of responsibility:

• Development and elaboration of multicentre, international study protocols
• Development and coordination of all regulatory components of clinical trials (including registry, AMG and MDR studies) with mapping of all aspects of project management from application, implementation, site management, analysis and closure
• Coordination and planning of monitoring
• Familiarisation with the respective specialist areas of the project teams contact person for the trial sites and monitors (including Germany, UK, USA, South America)
• Development of project-specific work plans including milestones
• Independent planning and implementation of the on-site monitoring in Germany
• Organisation and management of regular project meetings, partly with external experts, including tracking of project progress
• Close and trusting communication with the participating scientists and clinkers
• Central statistical monitoring and analysis of the findings and autono­mous preparation of study reports
• Submission of studies via European portals (e. g. CITIS), communica­tion with german, european and american authorities (including BFARM, EMA and FDA)
• Collaboration in the creation/modification of monitoring-specific docu­ments (slides, monitoring manual, SOPs)
• Participation in and implementation of meetings (Jour fixe, CRA meetings)
• Structured reporting to study management and coordination group
• Independent coordination of travel activities
• Research assistants will be given sufficient time for their own scientific work in accordance with their employment contract

Your profile:

• Degree in the natural sciences (diploma, master's degree)
• At least two years of professional experience as project manager with experience in monitoring projects
• Experience in statistical analysis methods and meta-analyses
• Experience in conducting multicentre clinical trials
• Proven experience in project management with online-based tools
• Personal responsibility, ability to work in a team, good organisational skills, ability to work independently on projects
• Willingness to travel extensively (scientific liason)
• Proven communication skills and confident appearance
• Written and spoken knowledge of English and German
• Excellent analytical skills; formal training in epidemiology and/or statistics is preferred
• Ability to effectively engage practicing clinicians, scientists, key opinion leaders and regulatory authorities
• Proven success in study design and implementation with diverse research teams
• Proficiency with Microsoft Office, RevMan and other statistical software
• Knowledge of data protection and data management (Redcap desired)

We offer:

• Entgeltgruppe EG14 according TVöD-VKA-K. The grouping takes place under consideration of the qualification and the personal requirements
• A future-oriented, varied and challenging job with a high degree of personal responsibility and your own room for manoeuvre in an institution at the highest medical and scientific level
• A correspondingly highly professional, yet cordial working atmosphere in interdisciplinary teams
• Support in continuing education as an integral part of our corporate culture