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    Clinical Research Associate

    Novartis
    2+ years
    Not Disclosed
    Mumbai
    10 Jan. 18, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Position: Clinical Research Associate
    Location: Mumbai (Head Office)
    Job ID: REQ-10036180
    Posted on: 3 Days Ago
    Application Deadline: January 25, 2025

    Company Overview

    Novartis is committed to reimagining medicine to improve and extend people's lives. As a global leader in healthcare, Novartis strives to provide innovative solutions with a mission to become the most valued and trusted medicines company in the world. The company's work is driven by the dedication and expertise of its associates, working together to achieve their shared goals.

    Role Overview

    The Clinical Research Associate (CRA) is responsible for managing site relationships, ensuring the successful execution of clinical trials (Phase I-IV) for Global Drug Development (GDD) within the country. The CRA will perform both on-site and remote monitoring activities, ensuring adherence to protocols, ICH/GCP guidelines, local regulations, and SOPs. The role involves proactive management of site performance, recruitment, and quality, acting as the primary point of contact for site-related matters.

    Key Responsibilities

    • Site Relationship Management:
      • Serve as the frontline liaison between Novartis and study sites, ensuring successful collaboration and meeting expectations.
      • Manage assigned study sites, conducting trials in accordance with the Monitoring Plan and Novartis procedures.
      • Perform Site Initiation Visits, ensuring site personnel are fully trained on trial-related aspects.
    • Monitoring & Compliance:
      • Conduct continuous site monitoring activities (both onsite and remotely) and ensure compliance with protocols, ICH/GCP, regulations, and data privacy requirements.
      • Promote a compliance culture, ensuring human subject protection and the reliability of trial results.
      • Perform Site Closeout activities in accordance with SOPs, ensuring site awareness of follow-up activities and archiving requirements.
    • Collaboration & Performance Management:
      • Work with Clinical Project Managers, CRA Managers, and medical teams to optimize recruitment, site development, and data quality.
      • Participate in audit and inspection readiness activities and implement corrective actions where needed.

    Qualifications

    • Education:
      • Degree in a scientific or healthcare discipline.
    • Experience:
      • Minimum 2 years of pharmaceutical industry experience or other relevant experience.
      • Experience in central/in-house or field monitoring.
    • Knowledge & Skills:
      • Familiarity with international standards (GCP/ICH, FDA, EMA).
      • Strong understanding of clinical monitoring, patient safety, data integrity, and protocol compliance.
      • Strong decision-making skills and ability to manage site performance effectively.

    Why Novartis?

    • Mission-Driven: Novartis is focused on reimagining medicine and improving lives globally.
    • Inclusive Culture: The company values diversity and promotes an inclusive, collaborative work environment.
    • Opportunity for Growth: Join a company committed to innovation and providing opportunities for personal and professional development.

    Additional Information

    Novartis is dedicated to building diverse teams that reflect the communities they serve. They strive for an outstanding, inclusive work environment where everyone can contribute and thrive.

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