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Clinical Research Associate
Novo NordiskClinical Research Associate overseeing clinical trials at Novo Nordisk. Ensuring compliance with protocols and regulatory requirements through monitoring and relationship building.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Oversee and manage assigned clinical trial sites, conducting on-site and remote monitoring visits to ensure compliance with protocols, ICH-GCP guidelines, and regulatory requirements.
- Drive the implementation of Risk-Based Quality Management (RBQM) principles to proactively identify, assess, and mitigate risks throughout study conduct.
- Build and maintain strong relationships with investigators, site staff, and cross-functional teams to support efficient clinical trial execution.
- Monitor site performance, recruitment progress, retention, and data collection to ensure study timelines and quality objectives are met.
- Ensure patient safety and data integrity by resolving discrepancies, managing adverse events, and maintaining inspection readiness.
- Provide site training and continuous support on study protocols, operational procedures, systems, and compliance requirements.
- Act as an ambassador for Novo Nordisk values at the site level, ensuring high-quality trial execution.
Requirements
What you’ll need- Bachelor’s degree in Life Sciences (or related field)
- minimum 1+ years’ experience in clinical trial monitoring or a relevant pharmaceutical industry/CRO role
- Strong understanding of ICH-GCP, regulatory requirements, and clinical trial methodology
- Demonstrated ability to ensure high-quality execution of clinical trial activities in compliance with ICH-GCP, regulatory requirements, and internal SOPs
- Ability to build and maintain strong relationships with internal and external stakeholders across all organizational levels
- Excellent written and verbal communication and stakeholder management skills
- Confident working in dynamic environments independently and as part of a team
- Strong organizational and time management skills, with the ability to manage multiple sites and priorities
- Strong project management capabilities with high attention to detail, integrity, and commitment to quality and patient safety
- Proficiency in digital tools, including EDC, CTMS, eTMF, and other clinical trial software
- Strong problem-solving and decision-making capabilities, including proactive risk identification and mitigation
- Strong attention to detail and commitment to high-quality, compliant trial conduct
- Open to embracing better ways of working and continuous improvement, including new technologies and digital tools
- Up to 70% travel required, in alignment with local Regional/CDC requirements
Benefits
Comp & perks- continuous learning
- career development
- benefits tailored to your life and career stage
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 monitoringRisk-Based Quality ManagementICH-GCPregulatory requirementsclinical trial methodologydata integrityadverse event managementsite performance monitoringrecruitment progress trackingdata collection
Soft Skills
relationship buildingstakeholder managementcommunication skillsorganizational skillstime managementproject managementproblem-solvingdecision-makingattention to detailcommitment to quality