Specialist, Central Monitoring Manager

Company: Disability Solutions
Location: Spring House
Posted on: September 19, 2023

Job Description:

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Specialist, Central Monitoring Manager. This position can be located remotely within the United States. The Specialist CMM executes and manages the Analytical Risk-Based Monitoring (ARBM) processes and day-to-day activities for three to five trials of medium complexity trials in conformance to all relevant laws, regulations, guidelines, policies and procedures. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies. Key Responsibilities:

• Lead the cross-functional study team in the completion of ARBM-related study start-up processes, such as the protocol assessment, protocol de-risking, iARBM plan creation, ARBM-related input into the monitoring guidelines and the creation of tSDV specifications with a high degree of influence on translating ARBM concepts.
• Analyzes data from available reporting mechanisms and dashboards and concisely organizes potential risks for reporting out at the Central Monitoring Working Group (CMWG).
• Identifies CtQ items that require the development of study specific reports and in turn works with statisticians & programmers to translate those CtQs into easily interpretable reports.
• Exhibit adequate leadership skills to support ARBM strategies and leads the cross-functional CMWG.
• Analyzes and identifies risks requiring further review and follow up as part of routine CMM work and CMWG conduct and ensures appropriate actions are taken by the central/local team members (e.g. GCO, Portfolio Delivery, IDAR) to investigate, resolve and document potential risks identified via CMM data review, including ensuring adequate documentation of resolution.
• Provides input into lessons learned activities related to ARBM.
• Contributes to the ongoing development of the ARBM model of clinical trial management and related processes.
• May support activities driven by the RM-CM Capability Center which would include development and oversight of Study-specific reports, analysis of Central Statistical Surveillance and support to enhancements of existing analytical tools.
• As needed, support Innovation Projects which may include but are not limited to participation in requirements development, user acceptance testing and identification of improvements to existing and new analytical tools.
• May perform other work-related duties as assigned.

Keywords: Disability Solutions, Philadelphia , Specialist, Central Monitoring Manager, Executive , Spring House, Pennsylvania