Clinical Affairs Manager
Vor 4 Tagen
A pioneering digital health company is looking for a Clinical Affairs Manager to lead clinical strategy and operations for an AI-powered remote monitoring platform focused on Parkinson's disease and other movement disorders. The role is critical in ensuring the technology is scientifically validated, clinically meaningful and regulatory-ready.
Key Responsibilities
- Lead the design, implementation, and management of clinical trials and observational studies
- Coordinate with investigators, CROs, and internal teams to ensure data quality, compliance and timely delivery
- Support regulatory submissions (FDA, MDR, CE) and collaborate with quality teams to maintain audit readiness
- Build and manage collaborations with hospitals, clinicians and research institutions
- Translate clinical and real-world data into evidence for publications, white papers and medical communications
- Provide clinical insights to guide product development, usability and go-to-market strategy
Candidate Profile
- Advanced degree in life sciences, biomedical engineering, nursing, or related field (PhD, MD, MSc, or equivalent)
- Proven experience managing clinical studies in digital health, medical devices or connected technologies
- Knowledge of GCP, ISO 14155 and regulatory frameworks (FDA, MDR)
- Strong project management, collaboration and communication skills
- Experience in neurology, movement disorders, digital biomarkers or SaMD is desirable
- Strong language skills in English and German
Role Highlights
- Shape the future of neurological care through cutting-edge digital health innovation
- Work at the intersection of AI, clinical science and real-world patient care
- Competitive compensation, equity and benefits
- Flexible, inclusive and intellectually stimulating culture
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