Job Description
Join NovoMed Pharma AG, a global leader in innovative therapeutics, as we pioneer the next generation of treatments for rare diseases. We seek a dynamic Senior Clinical Research Associate to lead complex clinical trials across Europe and North America. This pivotal role combines scientific rigor with operational excellence in a fast-paced, collaborative environment. Enjoy competitive compensation, comprehensive benefits, and opportunities to shape the future of medicine.
Responsibilities
- Design and execute Phase II-III clinical trials adhering to ICH-GCP and FDA/EMA regulations
- Monitor investigational sites to ensure protocol compliance and data integrity
- Manage clinical documentation, including CRFs, SAEs, and regulatory submissions
- Collaborate with cross-functional teams (medical, biostatistics, regulatory) on trial strategies
- Lead risk-based monitoring and vendor management activities
- Contribute to SOP development and process improvement initiatives
Qualifications
- MSc/PhD in Life Sciences, Pharmacy, or related field with 5+ years clinical research experience
- Certified CRA (ACRP/SoCRA) or equivalent certification required
- Demonstrated expertise in oncology or rare disease therapeutic areas
- Proficiency in EDC systems (e.g., Medidata Rave, Oracle Inform)
- Fluency in English and German; French proficiency highly valued
- Strong analytical skills with attention to regulatory compliance