Clinical Affairs Manager (all gender) (Referent/in - clinical studies (CRA))

With over 20 years of industry experience, ALTEN Consulting Services GmbH offers its well-known customers from industry and business highly specialized engineering and IT services for the joint realization of cross-industry and cross-technology solutions. Competence, commitment, and passion connect all our employees at ALTEN Consulting Services GmbH. In doing so, a partnership-based cooperation, a strong sense of "WE," personal contact with our customers, and the creativity of each individual are always the focus. Become part of our success story too.

Clinical Affairs Manager (all gender)

Make it happen YOU...

• plan and coordinate PMCF as well as clinical evaluation activities across the entire product portfolio and ensure MDR compliance
• assess the need for additional clinical data collection after being placed on the market together with internal stakeholders
• develop strategies for the generation, analysis, and use of PMCF data to ensure clinical safety, performance, and clinical benefit
• create and maintain PMCF plans as well as PMCF reports based on post-market surveillance data, clinical studies, and scientific literature
• support the creation of clinical evaluation documentation by incorporating preclinical, non-clinical, and clinical data
• work closely with Product Management, FE, Regulatory Affairs, and external partners and ensure successful cross-functional coordination

Be our forward thinker YOU...

• have a completed degree in medicine, natural sciences, engineering, or a comparable qualification
• bring relevant professional experience in the field of Clinical Affairs as well as sound knowledge of the EU-MDR and relevant MDCG guidelines
• possess practical experience in clinical evaluation, PMCF, and the requirements of Clinical Lifecycle Management
• have a good understanding of clinical research methods, study designs, biostatistics, and information management
• ideally know magnetic resonance technology as well as regulatory frameworks in the USA and China
• have business-fluent English skills; good German skills are an advantage

A home where people learn and thrive

• Future-oriented workplace with a permanent employment contract
• Attractive compensation
• Mobile working by arrangement
• Individual internal and external training
• Flexible working hours with a flexitime account system
• Personal contact person

You can find further information at: www.alten-consulting.de

We value diversity and therefore welcome all applications - regardless of gender, nationality, ethnic and social origin, religion / worldview, disability, age, as well as sexual orientation and identity.

Severely disabled persons will be given preferential consideration if they are equally qualified.

Apply now via our online application form.