Clinical Research Associate (CRA) at Novo Nordisk

Your new position

As CRA you will drive study quality and performance through risk-based monitoring and proactive risk management, collaborating effectively with site staff and cross-functional teams to ensure successful execution of the trial. Your responsibilities will be

• Site Management & Monitoring: You will oversee and manage assigned clinical trial sites, conducting on-site and remote monitoring visits in accordance with the Monitoring Plan, Protocol, ICH-GCP, internal SOPs, and applicable regulatory requirements. Responsible for additional tasks as assigned by affiliate/CDC – COM/TA Head
• Quality Oversight: You will drive the implementation of RBQM principles to ensure high-quality execution of clinical trial activities
• Stakeholder Collaboration & Communication: You will actively engage with site staff and collaborate with cross-functional teams to support strong site relationships and ensure efficient clinical trial execution

This position is required flexibility to travel as required.

Your new department

•  You will be part of the Clinical Development Centre (CDC) in NN South African office with 45 employees. You will be working closely with global and regional clinical operations, medical, and development teams. The CDC plays a critical role in enabling efficient trial start-up, optimizing site selection strategies, and ensuring the successful execution of Novo Nordisk's clinical trial portfolio. In this role, you'll bridge the gap between strategic planning and operational execution, ensuring South African sites are positioned for success in delivering innovative treatments to patients with high quality.

Your skills & qualifications

You are expected to hold a bachelor’s degree in Life Sciences or related field and have at least 4 years’ experience in clinical trial monitoring or relevant pharmaceutical industry/CRO role. You have excellent written and verbal communication and stakeholder management skills

Moreover;

• 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.
• 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.
• Open to embracing better ways of working and identify opportunities for continuous improvement, including new technologies and digital tools.
• As a person you are confident working in dynamic environments independently and as part of a team and have attention to detail and commitment to high-quality, compliant trial conduct.