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Novo Nordisk

2-3 years

Not disclosed

Bangalore

B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences

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Job highlights

Work/Life Balance

Time management

challenging projects

Insurance

Role and Responsibilities:

  • Primary Contact: Serve as the main point of contact between site staff and Novo Nordisk, acting as an ambassador for the company.
  • Site Management: Lead site management for the selection, initiation, conduction, and closure activities of studies, ensuring compliance with local regulations, ICH-GCP, NN procedures, and protocol requirements.
  • Recruitment and Results: Responsible for recruitment at the site level and delivering results that impact the successful completion of the clinical program.
  • Coordination: Coordinate with CRM and RTM, communicating progress and critical issues that may affect trial progress.
  • Site Visits: Conduct efficient and accurate site selection visits, including analysis of site logistics and performance.
  • Patient Recruitment: Develop and implement patient recruitment strategies and mitigation actions.
  • Monitoring Activities: Regularly visit trial sites to perform required monitoring activities.
  • IT Systems: Use IT systems (e.g., IMPACT, EDC) proactively for site visit preparation, conduct, and source data verification in collaboration with the data management/logistics team.

Qualifications:

  • Education: Graduate in Medicine, Science, Pharmacy, or another relevant field.
  • Certifications: Certified in ICH GCP; additional qualifications in clinical research preferred.
  • Experience: 2-4 years as a Clinical Research Associate, with experience in 1-2 multinational clinical trials (phase 2-3) from site initiation to closure.

Application Link

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Clinical Research Associate | Novo Nordisk

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