Job Description
Join NovoNordics Pharma's groundbreaking clinical development team and shape the future of pharmaceutical innovation. We're seeking a dynamic Senior Clinical Research Manager to oversee pivotal phase II/III trials for novel biologics. You'll lead cross-functional teams, ensure regulatory compliance, and accelerate life-changing therapies to market. Collaborate with global experts in our state-of-the-art Copenhagen facilities while enjoying Denmark's exceptional work-life balance and world-class healthcare benefits.
Responsibilities
- Design and execute global clinical trial protocols for CNS therapeutics
- Manage CRO partnerships and vendor relationships across 5+ countries
- Ensure GCP/ICH compliance and FDA/EMA regulatory submissions
- Lead risk-based monitoring strategies for 15+ trial sites
- Analyze complex trial data and prepare FDA/EMA submissions
- Mentor junior CRAs and optimize clinical operations workflows
- Represent clinical development at internal and external audits
Qualifications
- MSc/PhD in Life Sciences, Pharmacy, or related field
- 8+ years clinical research with 4+ in CNS therapeutics
- Certified CRA (ACRP/SoCRA) or equivalent certification
- Proven experience managing global phase II/III trials
- Expertise in EDC systems (Medidata Rave) and ePRO solutions
- Strong knowledge of FDA/EMA regulatory requirements
- Fluency in English with Danish proficiency preferred
- Experience with biologics and immunotherapy trials