Job Description
Join NovoPharma AG, a global leader in innovative pharmaceutical solutions, as we pioneer the next generation of therapeutics. We seek a dynamic Senior Clinical Research Manager to lead pivotal clinical trials across Europe, ensuring regulatory compliance and therapeutic excellence. This role offers the opportunity to shape critical drug development pipelines while collaborating with top-tier scientists and regulatory experts in our state-of-the-art Basel facility.
Responsibilities
- Design and oversee global clinical trial protocols in accordance with ICH-GCP standards
- Lead cross-functional teams of CRAs, medical writers, and data managers
- Manage trial budgets exceeding CHF 5M and ensure on-target delivery
- Interact with regulatory agencies (EMA, FDA) for submissions and inspections
- Analyze complex clinical data and prepare safety/efficacy reports
- Mentor junior staff and implement process optimization initiatives
Qualifications
- PhD or PharmD in Life Sciences with 8+ years clinical research experience
- Proven track record of managing Phase II-III trials in oncology/neurology
- Expertise in EMA/FDA regulatory requirements and GCP compliance
- Strong proficiency in eCRF systems (e.g., Medidata Rave, Veeva Vault)
- Certified CRA (ACRP/SoCRA) or equivalent qualification
- Fluency in English and German; French advantageous