Jitendra Arora

Clinical and Health Research Professional

Role
Ccra at IQVIA
Location
Mumbai, MH, IN
LinkedIn followers
500 followers
Healthcare & Human ServicesView LinkedIn profile

About Jitendra Arora

I have completed PG Diploma in Clinical Research from IICR and B. Pharmacy from SKIT…

Experience

  1. Ccra

    IQVIA

    Mar 2025 — Present · Mumbai, IN

    Act as the central communication link between the Senior Global Trial Manager (SGTM) and the CFSP Clinical Monitoring Department.• Attend all assigned Study Team meetings (in person or via teleconference) and ensure timely information flow between teams.• Drive the collection, input, and global implementation of required study documentation (e.g, Site Monitoring Plan).• Communicate key updates from the Trial Team to Monitors and relay field feedback to the SGTM and study team.• Follow up on key study milestones: start-up timelines, site activation, recruitment progress, and database closure.• Coordinate and organize initial and refresher training for monitors during site selection, study start-up, and close-out phases.• Participate in initiation, monitoring, and close-out visits when needed; provide ongoing support to monitors.• Respond to monitor queries and maintain a structured Q&A log; escalate critical issues as appropriate.• Review monitoring visit reports (Evaluation, SIV, Monitoring, and Termination), identify trends, and provide feedback.• Actively support Investigator Meetings and present on study procedures, CRF completion, GCP, and monitoring plans if needed.• Support Trial Master File (TMF) maintenance with the SGTM to ensure inspection readiness at all times.• Coordinate study tools and forms, customize templates, and track site-level documentation.• Organize CFSP Clinical Monitor calls; document attendance, generate minutes, and file meeting outputs.• Analyze monitoring KPIs and support quality oversight and data cleaning efforts.• Collaborate with SGTM and DLMs on monitor resourcing and workload planning.• Ensure communication, documentation, and monitoring activities meet regulatory and ethical standards.

Education

  • Rajasthan University of Health Science

    B, Pharmacy

  • Indian Institute of Clinical Research

    PG Diploma, CROP

  • Swami Keshvanand Institute of Pharmacy

    Bachelor of Pharmacy - BPharm, Pharmacy

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