Senior Manager Clinical Affairs in Bayern bei Siemens Healthineers

Do you want to help create the future of healthcare? Our name, Siemens Healthineers, was selected to honor our people who dedicate their energy and passion to this cause. It reflects their pioneering spirit combined with our long history of engineering in the ever-evolving healthcare industry.

Then come and join our global team asSenior Manager (f/m/d) Clinical Affairs to support our Business Areas/Lines, Business Horizontals and Technology Excellent Units in close cooperation with our country organizations in the application-oriented interpretation and implementation of global clinical requirements for in-vivo and in-vitro diagnostic medical devices.

Choose the best place for your work – Within the scope of this position, it is possible, in consultation with your manager, to work mobile (within Germany) up to an average volume of 60% of the respective working hours.

Your tasks and responsibilities:

• You guide Siemens Healthineers (SHS) Units in all clinical matters; this includes
• evaluation of medical devices and performance evaluation of in-vitro diagnostics (IVDs), their planning and determination of relevant data sources, systematic literature search and scientific evaluation and presentation of relevant data
• global post-market clinical follow-up activities, including post-market clinical trials and vigilance
• qualification and monitoring of clinical trial sites
• You support the SHS Units in the
• implementation of global regulations for clinical investigations, clinical studies, and performance evaluation studies
• establishment of clinical development strategies, planning and execution of clinical investigations/studies
• communication with national competent authorities, ethics committees and contract research organizations
• qualification and monitoring of clinical investigation/study sites
• You analyze global clinical regulations and establish SHS-wide provisions that detail the conduct of required clinical activities. In addition, you effectively communicate these clinical regulations to the global SHS clinical community
• Together with subject matter experts you identify possible improvement potentials not only in clinical affairs but also in the post market processes, develop solutions, and optimize interfaces and communication channels
• You provide trainings and coach SHS units and external customers e.g., in global clinical processes and communication with national competent authorities and clinical investigators. This includes creation of corresponding training concepts and training material
• You monitor and audit clinical investigation/study sites in accordance with ISO 14155 and support clinical investigation/study sites during an audit or inspection.
• You work with international industry associations and standard organizations to harmonize global clinical regulations and standards

To find out more about the specific business, have a look at https://www.siemens-healthineers.com/products-services

Your qualifications and experience:

• You have a university degree in human medicine or biology and/or equivalent qualification and experience
• You have several years of professional experience in a Clinical Affairs function or equivalent in the medical device/IVD industry, an academic clinical research center or a contract research organization
• You have profound knowledge of the regulatory requirements for medical devices and IVDs and are proficient in the most current version of clinical MDCGs (such as MDCG 2020-6 incl. relevant parts of MEDDEV 2.7/1) and ISO 14155. Ideally you have clinical expertise not only for the European Union but also for other countries such as China and the USA
• You can demonstrate profound knowledge and practical experience in managing clinical investigations and/or performance evaluation studies and bring experience in Post Market Clinical Follow Up
• You have experience in the management and monitoring of clinical trials and/or (clinical) performance evaluation studies
• You have gained fundamental knowledge in clinical research methodologies, including clinical investigation/study design, biostatistics, information management (e.g., use of scientific literature databases), and medical writing
• Preferable you can contribute already existing expertise in post-market aspects and are willing to familiarize yourself in further regulatory affairs and quality management topics

Your attributes and skills: