Lead, Central Monitoring & Rbqm For Global Trials (San Miguel)

Job Summary Parexel FSP is looking for a Manager, Central Monitoring in Argentina! Candidates must have at least 7 years of overall experience and a minimum of 1 year directly in Central Monitoring. The Manager, Central Monitoring is accountable for centralized monitoring activities for integral and/or complex 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 well as a comprehensive review of supplemental operational data/trends and issues to be interpreted, reported and presented to the study teams. The Manager will be responsible for supporting several studies within a therapeutic area and program-level, working 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 continued process improvement and innovation activities, and industry collaborations in central monitoring capabilities. Responsibilities
- Collaborate on Study Quality Risk Assessment: Participate in the development and refinement of the Study Quality Risk Assessment and Control Tracker (QRACT) to identify and manage study risks.
- Develop and Author the Central Monitoring Plan: Lead the creation of the Central Monitoring Plan, ensuring alignment with study‑specific needs and Risk‑Based Quality Management (RBQM) methodologies.
- Oversee 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 intervention.
- Facilitate Study Team Decisions: Present findings to clinical study teams, support root cause analysis, and provide recommendations for follow‑up actions to address identified risks.
- Document and Track Actions: Document outputs from Central Monitoring Review meetings, track decisions, and ensure timely closure of actions.
- Act as Central Monitoring subject matter expert.
- Represent Central Monitoring as a subject matter expert during audits, inspections, and within study teams on RBQM processes.
- Provide Oversight of Contract Research Organization (CRO) Activities: Partner with outsourcing management to align 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. Requirements
- 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 current and future business trends and apply them to centralized monitoring practices.
- Excellent written communication skills, with the ability to convey complex technical and analytical insights in a clear and concise manner.
- Aptitude for mathematical concepts, statistical methodologies, and data analytics, with a focus on interpreting KRIs and KPIs.
- Knowledge and experience with clinical databases, electronic data capture systems, quality control processes, and auditing procedures.
- Proficiency in Microsoft Office applications, with advanced skills in Excel for data manipulation and reporting.
- Preferred: Experience using CluePoints or similar centralized monitoring RBQM system.
- Site monitoring or data management experience a plus. Education Bachelor's Degree required. Minimum Years of Experience At least 7 years of relevant experience in the biotechnology/pharmaceutical industry, with a minimum of 1 year with direct Central Monitoring experience. #J-18808-Ljbffr Postúlate en Kit Empleo: kitempleo.com.ar/empleo/qc78c