If you’re passionate about clinical research and have a keen eye for detail, the role of Centralized Visit Report Reviewer II at Precision Medicine Group in Bangalore is an exciting opportunity to elevate your career. Here’s everything you need to know about this position.

About Precision Medicine Group

Precision Medicine Group is a leading healthcare organization dedicated to advancing the field of precision medicine. With a focus on leveraging data-driven approaches, we help clients deliver tailored solutions to improve patient outcomes. The company values innovation, collaboration, and excellence in all aspects of clinical trials and research.

Key Responsibilities in the Role

As a Centralized Visit Report Reviewer II, you will be an integral part of the clinical research process. Your responsibilities include:

1. Monitoring Visit Report Review:
   • Conduct thorough reviews of clinical monitoring visit reports to ensure compliance with study protocols, SOPs, and annotated guidelines.
   • Escalate site or protocol-related issues to Clinical Trial Managers (CTMs).
2. Collaboration and Communication:
   • Liaise with clinical monitoring staff for timely submission and approval of monitoring reports.
   • Provide insights and solutions during internal project meetings to enhance report quality and resolve action items.
3. Investigator and Site Evaluation:
   • Assess site and investigator performance based on monitoring reports.
   • Escalate concerns about adherence to protocols or study requirements to leadership.
4. System and Metrics Oversight:
   • Use Clinical Trial Management Systems (CTMS) to monitor key metrics, action items, and quality standards.
   • Ensure timely resolution of open action items and protocol deviations.
5. Risk and Quality Management:
   • Offer recommendations for quality improvement and risk mitigation plans.
   • Support staff with change management and develop tools for identifying study performance concerns.
6. Compliance and Training:
   • Attend required training to enhance performance.
   • Support regulatory and audit responses as needed.

Qualifications and Experience

To excel in this role, candidates should possess the following:

• Education:
  • Bachelor’s degree in life sciences (nursing, pharmacy, physiology, or related field) or equivalent experience.
• Experience:
  • Minimum of 3 years in clinical monitoring, trial management, or a similar role.
  • Familiarity with ICH GCP guidelines and clinical development processes.
• Skills:
  • Strong written and verbal communication abilities.
  • Proven organizational and time management skills.
  • Experience in reviewing or approving clinical monitoring visit reports.
  • Ability to analyze protocols, dashboards, and electronic data systems for risk assessment.

Essential Skills

• Attention to detail and problem-solving capabilities.
• Ability to work independently and collaboratively.
• Effective use of data-driven tools to identify and address project risks.
• Commitment to continuous learning and quality improvement.

Application Link

AD