Job Description
Join the global leader in innovative medicines as a Senior Clinical Research Associate at Novartis AG in Basel. You will be pivotal in advancing groundbreaking therapies through meticulous clinical trial oversight, ensuring regulatory compliance, and driving patient-centric research. This role offers unparalleled opportunities to shape the future of healthcare while working in a collaborative, innovation-driven environment.
Responsibilities
- Monitor clinical trial sites to ensure adherence to GCP, protocols, and regulatory standards
- Lead site initiation, interim monitoring, and closeout visits with comprehensive documentation
- Collaborate with cross-functional teams (CRA, PM, Medical) to resolve protocol deviations
- Analyze trial data and provide insights to optimize study efficiency and patient safety
- Maintain electronic systems (e.g., Rave, Medidata) for accurate data capture and reporting
- Contribute to risk-based monitoring strategies and site selection criteria
- Mentor junior CRAs and participate in process improvement initiatives
Qualifications
- Bachelor's degree in Life Sciences, Nursing, or related field (Master's preferred)
- Minimum 3 years of clinical monitoring experience in pharmaceutical trials
- Certified CRA (CCRA) or equivalent GCP certification required
- Proficiency in EDC systems and clinical trial management software
- Strong knowledge of ICH-GCP, FDA, and EMA regulations
- Exceptional communication skills with cross-cultural sensitivity
- Proven ability to manage competing priorities in a matrix organization
- Fluency in English and German; other languages advantageous