Centralized Visit Report Reviewer II

As a Centralized Visit Report Reviewer II, you will play a crucial role in reviewing and approving site monitoring visit reports for various projects. Your responsibilities will include: - Reviewing clinical monitoring visit reports for assigned projects to ensure consistency across protocols and SOPs - Coordinating with clinical monitoring staff to ensure timely submission and approval of monitoring visit reports - Escalating open action items and protocol deviations for timely resolution - Attending project meetings to provide feedback for improving report quality and resolving action items promptly - Communicating trends, issues, and safety concerns to support clinical trial delivery and patient safety - Completing necessary trainings to enhance job performance and knowledge - Supporting staff with change management - Developing reporting tools and processes to address study performance concerns early - Serving as a subject matter expert on visit reports, trends, issues, and actions - Collaborating with study leadership to identify areas for improvement in site monitoring performance - Performing any other duties as assigned by management Qualifications required for this role: - Bachelor's Degree in a life science-related field or equivalent combination of education and experience - Minimum 3 years of experience in clinical monitoring or clinical trial management - Working knowledge of ICH GCP guidelines and the clinical development process Other skills and abilities needed: - Effective oral and written communication skills - Strong organizational and time management skills - Ability to work independently or in a team - Proficiency in reviewing and approving clinical monitoring visit reports - Capability to extract relevant information from various sources to assess risk - Experience in mentoring junior team members Please note that any data provided as part of the application process will be handled in accordance with our Privacy Policy. If you require accommodation for the application process or have any accessibility limitations, please contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. We would like to caution you against potential fraudulent job offers from unauthorized individuals or organizations. Our company follows a formal interview process and will not extend job offers without prior communication with our recruiting team and hiring managers.,