Serving as the primary liaison between Novo Nordisk, clinical sites, and cross-functional study teams, conducting on-site and offsite monitoring visits in accordance with ICH-GCP, SOPs, and regulatory requirements
Ensuring patient safety and data integrity by monitoring site data, resolving discrepancies, and managing adverse events in full compliance with protocols and regulatory standards
Overseeing site performance, recruitment progress, retention, and data collection to ensure study timelines and quality objectives are consistently met
Building and maintaining strong relationships with investigators and site staff to support the Novo Nordisk drug pipeline
Driving the implementation of Risk-Based Quality Management (RBQM) principles to proactively identify, assess, and mitigate risks throughout study conduct
Managing IP, study supplies, essential documents, and equipment across sites to ensure proper accountability and compliance
Leading site training and providing continuous support on study protocols, operational procedures, systems, and compliance requirements
Maintaining inspection readiness throughout all trial stages and providing support during audits and inspections
Collaborating with Trial Managers, Study Start-up teams, and Vendor Managers to ensure alignment and smooth study execution
Sharing site feedback and engagement insights to inform protocol updates and operational planning

Master's degree in Life Sciences or related field (minimum requirement)
1+ years' experience in clinical trial monitoring or a relevant pharmaceutical industry/CRO role
Strong understanding and knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trials methodology
Demonstrated 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
Strong organizational and time management skills, with the ability to manage multiple sites and priorities simultaneously
Proficiency in digital tools, including electronic data capture (EDC) systems, CTMS, eTMF, and other clinical trial software
High attention to detail, integrity, and commitment to quality and patient safety
Problem-solving and decision-making capabilities, including proactive risk identification and mitigation
Confidence working independently and as part of a team in dynamic environments
Openness to embracing better ways of working and identifying opportunities for continuous improvement, including new technologies
Flexibility to travel as required.

Clinical Research Associate I

Key skills