Amit Kumar

About Amit Kumar

Experienced Clinical Research Professional with a proven track record of success and over…

Experience

1. Global Report Reviewer Central Site Report Reviewer Scan Report Reviewer

   Syneos Health

   Apr 2024 — Present · Gurugram, IN

   Execute CRR activities for the study based on the defined Monitoring Strategy, prioritizing patient safety, protocol/GCP/regulatory compliance, and data integrity.• Support the development of annotated visit reports, including PSV, SIV, IMV, COV, and SCAN.• Review and ensure the quality and accuracy of site and central monitoring documentation (e.g, site monitoring calls, visit reports, site letters, and central monitoring reports). Confirm that these documents accurately reflect site management activities, trial conduct, and any risks related to protocol/GCP compliance, patient safety, or data integrity.• Document requested revisions and approvals in CTMS, ensuring all deliverables meet sponsor specifications and deadlines.• Assess factors impacting patient safety and clinical data integrity at investigator/physician sites, including protocol deviations, violations, sponsor requirements, and pharmacovigilance concerns.• Immediately escalate serious issues to the CTM or PM.• Working on m-CTMS and Veeva Clinical.• Document observations during reviews and report protocol deviations or action items in the appropriate systems for follow-up by CRA/CM or other relevant team members. May also evaluate CRA/CM report quality, identify risks and trends, and summarize findings for CTM review and action planning.• Participate in clinical monitoring/project staff meetings and attend clinical training sessions as required for the project. Stay engaged in project discussions and email correspondence to maintain an up-to-date understanding of project status and progress.• Demonstrate a strong understanding of cross-functional roles in ensuring compliance and study delivery per protocol, SOPs, ICH GCP, and local regulations. May also assist in CTM activities such as protocol deviation management, action item management, and other related tasks.

Education

• Brigadiyar Hoshiyar Singh Inter College

  Secondary school

  2002 — 2003

• Rabindranath Tagore University

  Master of Public Health - MPH

  2022 — 2024

• Shree Satyanarayan Inter College Shamli

  Intermediate

  2003 — 2005

• Chaudhary Charan Singh University

  Bachelor's degree

  2005 — 2008

• CRA School of Montreal, Canada

  Certificate

  2008 — 2009

• Clinical Research Education and Management Academy

  Advanced Post Graduate Diploma in Clinical Research

  2008 — 2009