Novo Nordisk este o companie globală din domeniul sănătății, axată pe dezvoltarea de tratamente pentru obezitate și diabet, cu peste 25 de ani de cercetare în aceste domenii. Fondată în 1923, compania produce medicamente menite să sprijine pacienții în diferite etape ale vieții și lucrează pentru consolidarea siguranței și integrității produselor sale, inclusiv prin eforturi de combatere a medicamentelor falsificate. Activitatea sa cuprinde cercetarea farmaceutică, îngrijirea pacienților și eforturi mai ample pentru îmbunătățirea accesului la tratamente esențiale.
Clinical Research Associate / Senior Clinical Research Associate - Novo Nordisk, Seoul
Manage clinical trial site monitoring, safety oversight, data integrity, and risk-based quality processes for Novo Nordisk in Seoul. Work with investigators, study teams, and clinical sites from study start-up through inspection readiness.
Descriere
- Manage assigned clinical trial sites from start-up through inspection readiness
- Act as the main liaison between Novo Nordisk, clinical sites, and cross-functional study teams
- Perform on-site and remote monitoring in line with monitoring plans, protocols, ICH-GCP, SOPs, and regulations
- Review site data, resolve discrepancies, and oversee adverse-event management
- Deliver data cleaning within the timelines defined by the Data Flow Plan
- Identify, assess, and mitigate risks through risk-based quality management
- Track site performance, recruitment, retention, and data collection
- Address site issues before they affect study timelines or quality
- Manage investigational medicinal products, supplies, equipment, and essential documents, including the Investigator Trial Master File
- Maintain sites in an inspection-ready state
- Train site staff on protocols, procedures, and clinical systems
- Provide site insights for protocol updates, patient engagement, and operational planning
- Mentor junior CRAs and manage complex trials and operational challenges at Senior CRA level
- Serve as lead CRA, take on part of a trial manager role, and represent the local clinical organisation in meetings and working groups when required
Cerințe
- A bachelor's degree or higher in life sciences or a related discipline
- At least five years of experience in clinical trial monitoring or a relevant pharmaceutical or CRO position
- Strong command of ICH-GCP, regulatory requirements, and clinical trial methodology
- Demonstrated ability to execute trials with high quality and compliance
- Excellent communication and stakeholder management capabilities
- Strong organisation, time management, and project management skills
- Effective problem-solving and decision-making abilities
- A proactive approach to identifying and reducing risk
- Proficiency with EDC, CTMS, eTMF, and other clinical trial systems
- Ability to work independently and collaboratively in a changing environment
- Willingness to travel as needed
Beneficii
- Practical experience across clinical trials
- Access to CRA training sessions
- Learning opportunities with experienced colleagues
- Chances to mentor others and take on lead responsibilities
- A collaborative and supportive team setting
- Professional development through broader responsibilities
- Travel flexibility as part of the role