(Junior) Manager Clinical Research (m/f/d)

Fresenius Medical Care is the world’s leading provider of products and services for individuals with renal diseases of which around 3.9 million patients worldwide regularly undergo dialysis treatment. We care for more than 344,000 dialysis patients and provide our products in around 150 countries. With a strong focus on innovation, quality, and customer satisfaction, we have consistently achieved remarkable growth and established ourselves as a trusted brand in the dialysis market. 

Our Global Medical Office Team aims the planning, organisation and conduct of national and international clinical studies in accordance with respective laws and regulations with the goal of product registration or clinical studies for new therapeutic approaches or products with marketing authorization.

As the Manager Clinical Research (m/f/d) your tasks would include:

Tasks:

• Development of studies / study programs on innovative therapies or a defined therapy field within the Clinical Research department
• Medical-scientific input in the development, coordination and approval of the clinical trial protocol and accompanying documents
• Support of the project plans for the operational conduct of the clinial studies
• Coordination, control and management of compliance with regulatory requirements and official regulations
• Regular coordination and communication of the study portfolio with the relevant stakeholders from other areas (Care Enablement, Care Delivery, etc.) within the scope of the area of responsibility
• Contact to key opinion leaders and experts
• Internal and external presentation of study results and publication (congresses, publications, clinical evaluations, lectures, etc.)
• Ensuring the implementation of processes in accordance with the procedural instructions (SOPs)
• Development and maintenance of standard operational procedures for clinical research
• Selection of suitable third parties (e.g., CRO, freelancer monitors) to support the study projects
• Negotiating of legal and financial conditions with third parties (e.g., CRO, freelance monitors) as well as potential study sites
• Preparation, conception, planning and implementation of meetings with the coordinating/participating investigators
• Communication with all participating investigators, study teams as well as third parties e.g. regarding the conduct of the study in the individual countries or for the review of study documents
   

Requirements:

• Bachelor's degree required / Master's, PhD other degree desirable but not mandatory - in the natural sciences, pharmaceutical or medical field
• More than 2 years experience and knowledge in the operational conduct of clinical trials of medical devices and medicinal products, the regulatory requirements for the clinical trail as well as subsequent utilization of the clinical data (clinical evaluation, congresses, publications)
• Min. 2 years experience in the project management of clinical studies
• Experience in project management of clinical studies
• Knowledge and/or interest in nephrology/dialysis as well as further diseases and therapeutic methods
• Knowledge and/or interest in relevant regulations, e.g. ICH, GCP, MDR, AMG, ISO14155
• Experience in scientific work and scientific literature
• Advanced English skills (in spoken and written form)
• Willingness to travel, congress participation, occasionally on the weekends