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Clinical Research Associate
Novo NordiskClinical Research Associate overseeing clinical trial management and ensuring protocol compliance. Focusing on data integrity and patient safety in collaboration with site staff and cross-functional teams.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Provide strategic oversight and management of clinical trial sites within CDC and Ad Hoc affiliate
- Drive study quality and performance through risk-based monitoring and proactive risk management
- Collaborate effectively with site staff and cross-functional teams to ensure successful execution of the trial
- Conduct on-site and remote monitoring visits in accordance with the Monitoring Plan, Protocol, ICH-GCP, internal SOPs, and applicable regulatory requirements
- Drive the implementation of RBQM principles to ensure high-quality execution of clinical trial activities
- Actively engage with site staff and collaborate with cross-functional teams to support strong site relationships and ensure efficient clinical trial execution
Requirements
What you’ll need- Bachelor's degree in Life Sciences or related field minimum
- 2+ years’ experience clinical trial monitoring or relevant pharmaceutical industry/CRO role
- Strong understanding and knowledge of ICH-GCP guidelines, regulatory requirements and clinical trials methodology
- Demonstrated ability to ensure high-quality execution of clinical trial activities in compliance with ICH-GCP, regulatory requirements and internal SOPs
- Demonstrated ability to build and maintain strong relationships with internal and external stakeholders across all organisational levels
- Excellent written and verbal communication and stakeholder management skills
- Confident working in dynamic environments independently and as part of a team
- Strong organisational and time management skills, with the ability to manage multiple sites and priorities
- Project management capabilities with high attention to detail, integrity, and commitment to quality and patient safety
- Proficiency in digital tools, including electronic data capture (EDC) systems, CTMS, eTMF, and other clinical trial software
- Problem-solving and decision-making capabilities, including proactive risk identification and mitigation
- Attention to detail and commitment to high-quality, compliant trial conduct
- Open to embracing better ways of working and identify opportunities for continuous improvement, including new technologies and digital tools
- Flexibility to travel as required.
Benefits
Comp & perks- We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
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 monitoringICH-GCP guidelinesregulatory requirementsclinical trials methodologyproject managementattention to detailproblem-solvingdecision-making
Soft Skills
communication skillsstakeholder managementorganizational skillstime managementrelationship buildingcollaborationindependenceflexibilitycommitment to quality