Novo Nordisk
Novo Nordisk
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 - Vancouver Onsite

Manage compliant clinical trial execution for Novo Nordisk in Vancouver, with responsibility for site monitoring, risk management, patient safety, and data integrity.

Descriere

  • Manage assigned clinical trial sites through on-site and remote monitoring visits.
  • Maintain compliance with study protocols, ICH-GCP, and applicable regulatory requirements.
  • Use Risk-Based Quality Management (RBQM) to identify, evaluate, and proactively mitigate study risks.
  • Monitor site performance, recruitment, retention, and data collection.
  • Investigate discrepancies and manage adverse events to safeguard patient safety and data integrity.
  • Maintain site readiness for inspections.
  • Train and support site personnel on protocols, procedures, systems, and compliance obligations.
  • Represent Novo Nordisk at the site level while developing effective relationships with investigators and site teams.
  • Work with cross-functional colleagues to support clinical trial delivery.
  • Advance study operations through continuous improvement, new technologies, and digital tools.

Cerințe

  • Bachelor’s degree in Life Sciences or a related discipline.
  • At least one year of experience in clinical trial monitoring or a relevant pharmaceutical or CRO position.
  • Knowledge of ICH-GCP, regulatory requirements, and clinical trial methodology.
  • Demonstrated delivery of high-quality trial activities in accordance with ICH-GCP, regulations, and internal SOPs.
  • Practical experience with clinical trial platforms including EDC, CTMS, and eTMF.
  • Strong organisational, time management, and project management capabilities.
  • Ability to oversee multiple sites and competing priorities with close attention to detail.
  • Sound problem-solving and decision-making skills, including the ability to identify and mitigate risks.
  • Excellent written and verbal communication skills.
  • Ability to establish effective relationships with internal and external stakeholders.
  • Capacity to work independently and collaboratively in a dynamic environment.
  • High integrity and a consistent commitment to quality and patient safety.
  • Willingness to adopt new technologies and digital tools.
  • Availability to travel up to 70% of the time.
  • Practical experience applying Risk-Based Quality Management (RBQM) in study conduct.

Beneficii

  • Ongoing learning opportunities
  • Support for career progression
  • Benefits aligned with your life and career stage
  • Short-term incentive (STI) opportunities may apply
  • Long-term incentive (LTI) opportunities may apply

Locuri de muncă similare

NVIDIA

Senior CPU Physical Design and DTCO Engineer

NVIDIA

Shape process technology choices for next-generation CPUs and assess their impact on power, performance, and area. Partner with foundry, IP, and hardware teams to advance early technology development for NVIDIA AI platforms.

Deschide