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Novartis

2 Years

Mumbai Remote

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

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Job highlights

Work/Life Balance

Time management

challenging projects

Insurance

Novartis, a global leader in reimagining medicine, is dedicated to improving and extending people’s lives. With an unwavering commitment to innovation, diversity, and collaboration, Novartis stands out as a trusted and valued name in the pharmaceutical industry. If you’re passionate about advancing healthcare and contributing to groundbreaking solutions, a career at Novartis offers the perfect platform to thrive.

Responsibilities in the Job

As a Clinical Research Associate (CRA) at Novartis, you will play a pivotal role in ensuring the successful execution of clinical trials. Your responsibilities include:

  1. Site Relationship Management:
    • Act as the primary liaison between Novartis and trial sites to foster effective collaboration.
    • Ensure trial sites meet expectations in deliverables and performance.
  2. Monitoring and Compliance:
    • Conduct on-site and remote monitoring of Phase I-IV Global Drug Development (GDD) trials.
    • Perform site initiation visits, ensuring thorough training for all trial-related personnel.
    • Ensure adherence to protocols, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) / Good Clinical Practice (GCP), local regulations, and Standard Operating Procedures (SOPs).
  3. Data and Quality Assurance:
    • Proactively manage site performance, focusing on recruitment and data quality.
    • Advocate for compliance and ethical integrity to ensure human subject protection and reliable trial results.
  4. Audit and Inspection Readiness:
    • Participate in audits and inspection readiness activities, ensuring the implementation of corrective actions as needed.

Qualifications and Skills

To be eligible for this role, you should possess:

  1. Educational Background:
    • A degree in a scientific or healthcare discipline.
  2. Experience:
    • A minimum of 2 years in the pharmaceutical industry or relevant experience.
    • Prior experience in central/in-house or field monitoring.
  3. Technical Knowledge:
    • Familiarity with international standards such as ICH/GCP, FDA, and EMA regulations.
    • An understanding of the core CRA responsibilities, including patient safety, data integrity, and protocol compliance.
  4. Soft Skills:
    • Strong communication and organizational skills.
    • A proactive approach to problem-solving and collaboration.

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