Clinical Research Associate

Summary
The CRA provides strategic oversight and management of clinical trial sites within CDC and Ad Hoc affiliate to ensure protocol compliance, data integrity, and the protection of patient safety and rights. The CRA drives 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.

Key Responsibilities
1. Site Management & Monitoring: 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
2. Quality Oversight: Drive the implementation of RBQM principles (including offsite visit) to ensure high-quality execution of clinical trial activities
3. Stakeholder Collaboration & Communication: Actively engage with site staff and collaborate with cross-functional teams to support strong site relationships and ensure efficient clinical trial execution

Main Job Tasks
1. Site Management & Monitoring
•Serve as the primary liaison between Novo Nordisk, clinical sites, and cross-functional study teams.
•Conduct on-site and remote visits in accordance with the Monitoring Plan, Protocol, ICH-GCP, internal SOPs, and regulatory requirements.
•Ensure patient safety and data integrity by monitoring site data, resolving discrepancies, and managing adverse events in compliance with the Protocol, Monitoring Plan, ICH-GCP, and regulatory requirements.
•Oversee site performance, recruitment progress, retention, and data collection to ensure study timelines and quality objectives are met.
•Build and maintain strong relationships with investigators and site staff to support the Novo Nordisk drug pipeline.
•Oversee and manage IMP, study supplies, essential documents, and equipment across sites to ensure proper accountability, quality, and compliance with protocol and regulatory requirements.
•Lead site training and provide continuous support on study protocols, operational procedures, systems, and compliance requirements to ensure high-quality trial execution.
•Identify and proactively resolve site-level issues to maintain study timelines and data quality.
•Maintain accurate and complete trial documentation, including the Investigator Trial Master File, in accordance with the TMF plan.
•Act as an ambassador for Novo Nordisk values at the site level.
•Contribute as SME as applicable
•Site budget negotiations and contract administration
•Coordination and facilitation of site payments

2. Quality Oversight
•Drive the implementation of RBQM principles (including offsite visit) to proactively identify, assess, and mitigate risks throughout study conduct.
•Ensure data cleaning cycle timelines are met in accordance with the Data Flow Plan.
•Maintain inspection readiness throughout all stages of the trial and provide support during audits and inspections.
•Ensure high-quality execution of clinical trial activities in compliance with ICH-GCP, regulatory requirements, and internal SOPs
•Ensuring reliable insights for data consumers who rely on COSMOS data 
•Never compromise Clinical Quality to secure satisfactory outcomes in audit/inspections and competitive readouts

3. Stakeholder Collaboration & Communication
•Communicate and collaborate with site staff and cross-functional teams, including Trial Managers, Study Start-up team, Vendor Managers, to ensure alignment, effective support, and smooth study execution.
•Participate in investigator meetings, CRA training sessions, and project/trial meetings, as applicable.
•Share site feedback and engagement insights to inform protocol updates, patient engagement initiatives, and operational planning, supporting continuous process improvement.
•Ensure site relationships via continuous value driven engagement

Key External Stakeholders
• Site staff (Investigators, study nurses/coordinators, etc.)
• Key Opinion Leaders (KOLs)
• Local Health Authorities
• IRBs / Ethics Committees
• Patient Advocacy Organizations
• Vendors / Suppliers
• Industry Committee Members

Key Internal Stakeholders
• Trial squads and Global Project Team (GPT)
• All respective clinical functions including CDC/Affiliate staff and key cross functional teams including CMM
• Clinical Operations Management Teams
• Country Management Teams (e.g. P&O, BU and so on)

Geographic Responsibility
• In alignment with local CDC requirements. 

Education
• Bachelor's degree in Life Sciences or related field minimum

Experience
• 2+ years’ experience clinical trial monitoring or relevant pharmaceutical industry/CRO role

Requirements (Skills, Knowledge and Competencies)
• 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.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.