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Centralized Visit Report Reviewer Ii

3+ years
Not Disclosed
10 June 3, 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

 

Job Title:

Centralized Visit Report Reviewer II


Location:

Bangalore, Karnataka, India


Job Type:

Regular Full-Time


Division:

Precision for Medicine – Clinical Solutions


Requisition Number:

5477


Position Summary:

The Centralized Visit Report Reviewer II (CVRR II) is responsible for reviewing and approving clinical site monitoring visit reports across multiple studies or portfolios. This role ensures report consistency, timely escalation of issues, and supports overall clinical trial quality and compliance with SOPs and regulatory standards. The CVRR II also collaborates with clinical monitoring teams and project leadership to enhance report quality and identify trends impacting trial delivery and patient safety.


Key Responsibilities:

  • Review and approve clinical monitoring visit reports ensuring compliance with protocols, SOPs, and sponsor expectations.

  • Communicate with clinical monitoring staff to ensure timely submission and approval of visit reports.

  • Escalate and follow up on open action items, protocol deviations, and safety concerns.

  • Participate actively in project meetings, providing feedback and suggestions to improve report quality and resolve issues.

  • Lead communication of trends, issues, and safety concerns to clinical trial management.

  • Ensure completion of all required trainings related to job performance.

  • Support change management and process improvements within the team.

  • Develop tools and reporting processes to identify and mitigate study performance concerns.

  • Serve as subject matter expert for visit reports, trends, and compliance audits.

  • Mentor junior team members as needed.

  • Collaborate with study leadership to identify monitoring performance improvement opportunities.


Qualifications:

Minimum Required:

  • Bachelor’s Degree in life sciences (nursing, medical, physiology, pharmacy, or related) or equivalent education and experience.

  • Minimum 3 years’ experience in clinical monitoring, clinical trial management, or equivalent.

  • Working knowledge of ICH GCP guidelines and clinical development processes.

Other Required:

  • Strong oral and written communication skills.

  • Excellent organizational and time management skills.

  • Ability to work independently and in teams.

  • Proficient in reviewing clinical monitoring visit reports.

  • Skilled at extracting and analyzing protocol and clinical data to assess risk.

  • Ability to mentor junior staff.