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Senior Clinical Research Associate
Novo NordiskClinical Research Associate providing oversight of clinical trial sites at Novo Nordisk. Ensuring protocol compliance and data integrity while driving quality through monitoring and relationships.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Provide strategic oversight of clinical trial sites, ensuring protocol compliance and data integrity
- Be the primary connection between Novo Nordisk and the sites conducting clinical trials
- Conduct on-site and remote monitoring visits in accordance with ICH-GCP and regulatory requirements
- Monitor site data, resolve discrepancies, and manage adverse events in compliance with protocols
- Oversee site performance, recruitment progress, retention, and data collection
- Lead site training and provide continuous support on study protocols, operational procedures, and compliance requirements
- Drive the implementation of Risk-Based Quality Management (RBQM) principles
Requirements
What you’ll need- A Bachelor's degree in Life Sciences or related field (minimum requirement)
- 2+ years' experience in clinical trial monitoring or relevant pharmaceutical industry/CRO role
- Strong understanding and demonstrated knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial methodology
- Excellent written and verbal communication and stakeholder management skills, with demonstrated ability to build and maintain strong relationships across all organizational levels
- Strong organizational and time management skills with the ability to manage multiple sites and priorities, coupled with project management capabilities and high attention to detail
- Proficiency in digital tools including electronic data capture (EDC) systems, CTMS, eTMF, and other clinical trial software
- Flexibility to travel as required
Benefits
Comp & perks- Opportunities to learn and develop
- Collaborate with talented colleagues
- Commitment to finding better ways forward
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial monitoringprotocol compliancedata integrityRisk-Based Quality ManagementICH-GCP guidelinesregulatory requirementsclinical trial methodologydata collectionadverse event managementsite performance oversight
Soft Skills
communication skillsstakeholder managementrelationship buildingorganizational skillstime managementproject managementattention to detailtraining and supportproblem-solvingflexibility