Manager, Central Monitoring/RBQM Programmer - FSP

Location: Any Region, REMOTE, United States of America, Alabama, United States, Alaska, United States, Arizona, United States, Arkansas, United States, California, United States, Colorado, United States, Connecticut, United States, Delaware, United States, Florida, United States, Georgia, United States, Hawaii, United States, Idaho, United States, Illinois, United States, Indiana, United States, Iowa, United States, Kansas, United States, Kentucky, United States, Louisiana, United States, Maine, United States, Maryland, United States, Massachusetts, United States, Michigan, United States, Minnesota, United States, Mississippi, United States, Missouri, United States, Montana, United States, Nebraska, United States, Nevada, United States, New Hampshire, United States, New Jersey, United States, New Mexico, United States, New York, United States, North Carolina, United States, North Dakota, United States, Ohio, United States, Oklahoma, United States, Oregon, United States, Pennsylvania, United States, Rhode Island, United States, South Carolina, United States, South Dakota, United States, Tennessee, United States, Texas, United States, Utah, United States, Vermont, United States, Virginia, United States, Washington, United States, West Virginia, United States, Wisconsin, United States, Wyoming, United States, Remote

Employment Type: Remote

The Manager, Data Analysis, is responsible for overseeing centralized monitoring activities for global and/or complex clinical trials, ensuring the effective configuration, execution, and maintenance of Risk-Based Quality Management (RBQM) systems. This role involves configuring studies within an RBQM platform, performing recurring data refreshes, troubleshooting errors in execution, and leveraging programming expertise to support advanced data analyses, automation, and reporting.

The Manager will play a critical role in interpreting and presenting Key Risk Indicator (KRI) and Key Performance Indicator (KPI) data, as well as conducting comprehensive reviews of supplemental operational data, trends, and issues. Proficiency in programming languages such as R, SQL, or SAS will be essential for creating custom analyses, automating workflows, and integrating data systems. As an integral member of the Central Monitoring team, the Manager will deliver actionable insights to drive decision-making and optimize trial performance.

Additionally, the Manager will oversee multiple studies within a designated therapy area, lead process improvement initiatives, and contribute to innovation in central monitoring capabilities through collaboration with cross-functional teams and industry partners. This role requires a combination of technical expertise, analytical problem-solving skills, and effective communication to succeed in a dynamic, fast-paced environment.

Job Duties:

• Act as a subject matter expert for the configuration, implementation, and execution of Central Monitoring RBQM system across studies.
• Maintain Central Monitoring Key Risk Indicators and Quality Tolerance Limit Libraries within Central Monitoring RBQM system to ensure standard deployment consistency and alignment with regulatory requirements.
• Coordinate with functional and cross functional stakeholders to develop configuration specifications for Central Monitoring in RBQM system.
• Provide operational expertise, training, and guidance as a point of escalation for Central Monitoring issues related to Central Monitoring RBQM system.
• Conduct central monitoring reviews in support of study central monitor.
• Participate in ongoing improvements in standardizing technologies, systems, processes, and training materials that support Central Monitoring and RBQM.
• Represent Central Monitoring in process improvement initiatives.
• May require 25% travel.

Job Requirements:

• At least 4 years of relevant biotechnology/pharmaceutical industry experience.
• Central Monitoring, site monitoring or data management experience a plus.
• Minimum 2 years with direct RBQM systems experience.
• Technical expertise in database design, system configuration, and report development, with experience in managing Risk-Based Quality Management (RBQM) systems or similar platforms.
• Proficiency in programming languages such as Python, R, SQL, or SAS, with the ability to develop scripts for data analysis, automation, and system integration.
• Working knowledge of the clinical drug development process, including ICH, GCP guidelines, and regulatory requirements.
• Aptitude for mathematical concepts, statistical methodologies, and data analytics, with a focus on interpreting Key Risk Indicators (KRIs) and Key Performance Indicators (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 and risk-based quality management solutions.

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