Clinical Research Associate I

Category:  Clinical Development
Location: 

Prague, Czech Republic, CZ

   

Clinical Research Associate I

Drive clinical excellence from protocol to patient – where your monitoring expertise ensures trial quality and patient safety across our global pipeline.

 

Your new role

As a Clinical Research Associate I, you'll provide strategic oversight of clinical trial sites across our global portfolio, ensuring protocol compliance, data integrity, and patient safety. You'll be the vital link between Novo Nordisk, clinical sites, and cross-functional teams, driving study quality through risk-based monitoring and proactive collaboration. This position is a maternity leave cover.

 

Your responsibilities will include:

  • 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

This role requires flexibility to travel as required and is based within our Global Trial Portfolio (GTP), Trial Operations EUCAN.

 

Your new department

Within R&D, you'll join our Clinical Development Centre (CDC) team in Czechia, working closely with local trial squads and the Global Project Team. As part of a collaborative network of CRAs, you'll play a critical role in ensuring our clinical trials are executed with the highest standards of quality, compliance, and patient-centricity, ultimately bringing life-changing medicines to patients worldwide.

 

Your skills & qualifications

We're looking for a detail-oriented Clinical Research Associate who thrives in dynamic environments and is passionate about ensuring trial excellence. You'll bring with you:

  • 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

 

Working at Novo Nordisk

Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations.

 

What we offer

There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.

Deadline

April 14th

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.