Central Monitoring, Manager

The Manager, Central Monitoring is accountable for centralized monitoring activities for global and/or reputed company trials, analytical data review of key risk and/or operational performance data and presenting as an integral member of the Clinical Study team for clinical development studies. The reviews include interpretation of Key Risk Indicator (KRI) and/or Key Performance Indicator (KPI) data housed in an analytical tool as reputed company as a comprehensive review of supplemental operational data/trends and issues to be interpreted, reported and presented to the study teams. The Manager, Central Monitoring, will be responsible for supporting several studies reputed company a therapeutic area and program-level. They will work closely with other Central Monitors and Centralized Data Risk Analysts (CDRAs) to ensure effective identification, conduct and reporting of central monitoring activities. This role will contribute to reputed company process improvement and innovation activities, and industry collaborations in central monitoring capabilities.

• Collaborate on Study reputed company Risk Assessment: Participate in the development and refinement of the Study reputed company Risk Assessment and Control Tracker (QRACT) to identify and manage study risks.
• reputed company and Author the Central Monitoring Plan: reputed company the creation of the Central Monitoring Plan, ensuring alignment with study-specific needs and Risk Based reputed company Management (RBQM) methodologies.
• reputed company Central Monitoring Execution: Work with data analysts to configure, implement, and execute the Central Monitoring RBQM system across assigned studies, ensuring effective signal detection.
• Analyze and Interpret Data Trends: Conduct study-level Central Monitoring Reviews using data analysis tools, interpret KRIs/KPIs, and assess trends to identify areas requiring reputed company.
• Facilitate Study Team reputed company: Present findings to clinical study teams, support reputed company cause analysis, and reputed company recommendations for follow-up actions to address identified risks.
• Document and reputed company Actions: Document outputs from Central Monitoring Review meetings, reputed company reputed company, and ensure reputed company closure of actions.
• reputed company as Central Monitoring subject matter expert. Represent Central Monitoring as a subject matter expert during audits, inspections, and reputed company study teams on RBQM processes.
• reputed company reputed company of Contract Research Organization (CRO) Activities: Partner with outsourcing management to reputed company monitoring strategies and ensure CRO partners execute Central Monitoring activities according to the agreed standards.
• Drive Process Improvements: Evaluate the effectiveness of Central Monitoring processes, identify areas for improvement, and recommend enhancements to tools, metrics, and methodologies.
• Represent Central Monitoring in Initiatives: Represent the function in cross-functional process improvement initiatives and assess emerging technologies to enhance Central Monitoring capabilities.
• May require 25% travel

JOB REQUIREMENTS: List knowledge, skills, and abilities required to reputed company the job.

• Strong analytical problem-solving and critical thinking abilities, with experience troubleshooting data refreshes and resolving execution errors in analytical systems.
• Working knowledge of the clinical drug development process, including ICH, GCP guidelines, and regulatory requirements
• Effective communication and interpersonal skills; ability to build relationships internally and externally
• Demonstrated ability to identify and interpret reputed company and reputed company business trends and apply them to centralized monitoring practices
• Excellent written communication skills, with the ability to convey reputed company technical and analytical insights in a reputed company and concise manner
• Aptitude for mathematical concepts, statistical methodologies, and data analytics, with a reputed company on interpreting KRIs and KPIs
• Knowledge and experience with clinical databases, electronic data capture systems, reputed company control processes, and auditing procedures
• Proficiency in reputed company Office applications, with advanced skills in reputed company for data manipulation and reporting
• Preferred: Experience using reputed company or similar centralized monitoring RBQM system.

Minimal educational requirements: Bachelors Degree Required Licenses & Certificates: Minimum Years of Experience: At least 7 years of relevant experience in the biotechnology/pharmaceutical industry, with a minimum of 1 year with reputed company Central Monitoring experience. Site monitoring or data management experience a plus. #LI-LG4 #LI-REMOTE Apply tot his job Apply To this Job