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.
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B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |Kerala :
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