Associate Director, Central Monitoring Lead United States of AmericaR-092####### CSL Behring L.L.C. Job Description The Associate Director, Central Monitoring (CM) Lead is an integral member of the Global Data Strategy & Innovation team within Clinical Development Operations. This role is responsible for leading the implementation and conduct of a cross-functional central monitoring strategy on assigned studies in accordance with processes developed internally to ensure compliance with ICH E6 R2. In addition, the CM Lead is responsible for mastering the Risk Based Monitoring (RBM) tools available to conduct both aggregate level and real-time reviews (e.g., Xcellerate platform) according to the Quality & Risk Management Plan and supporting functional plans. CM Lead works closely with other functional groups to gather requirements and develop functional oversight strategies for each study. The Associate Director, Central Monitoring Lead will play a critical role throughout all of the major study phases as a member of the Study Execution Team (SET). During startup, he/she will liaise with our eClinical team to ensure that the RBM tool is configured appropriately. In addition, the CM Lead will be a member of the cross-functional stakeholder team that conducts the up-front protocol risk assessment and will work with the Clinical Quality Control & Compliance (CQCC) team member to ensure appropriate and thorough identification of critical data and processes. Using the critical data and processes as a basis, the CM Lead will work with key SET members to facilitate selection of the appropriate key risk indicators (KRIs) to monitor and define their corresponding thresholds as applicable. Throughout study execution, the CM Lead will leverage all available RBM tools to perform regular clinical and operational data reviews. Based on these reviews, the CM Lead will use data to generate information that he/she turns into insights. The CM Lead will use these insights to deliver recommendations to the pertinent functional area stakeholders to take action during the Central Study Risk Monitoring meeting. He/she will oversee the study issues management process within the RBM tool in close collaboration with the SET lead to facilitate single source, full life cycle, issues management. During closeout, the CM Lead will ensure that necessary documentation from the RBM tools are in a final state and eventually filed in the eTMF. The incumbent should have demonstrable clinical development (particularly data management and clinical operations), exercise project management principles and possess risk-based monitoring experience. The CM Lead should comprehend all facets of the protocol and the output from risk identification and assessment. Critical thinking skills are necessary to define and analyze data from complex, overlapping domains to make well-supported decisions. The CM Lead must be able to see the bigger picture that enables identification of trends or outliers so he/she can target specific issues of importance for focused debate. Familiarity with Xcellerate is preferred. The CM Lead has the ability to work independently and to manage a complex and varied portfolio of studies. He/she will be responsible for growing the risk-based monitoring capability and developing the business case, inclusive of return on investment analysis, to grow the team based on workload. The CM Lead will have a strong customer focus and ability to build and maintain relations with stakeholders. Communication skills, both written and verbal, are a key component to the success of the role. * Support the risk assessment activities including definition of critical data and processes for all studies. * Map study critical data and procedures to key risk indicators and applicable thresholds to define a comprehensive oversight strategy. * Support the configuration of the RBM tool for each study by ensuring business requirements are accounted at setup. * Develop and proactively monitor key quality and risk indicators to enhance study data quality, support data driven decision making and risk mitigation strategies. Work with cross-functional team to define appropriate thresholds and intervention strategies. * Support development of a global KRI library and performance metrics to identify studies that may require further escalation. * Perform regular clinical and operational data reviews as described in QRMP and supporting functional plans to identify, evaluate, report on emerging trends, meaningful data anomalies, and detect potential fraud. * Oversee the study issues management process to facilitate single source, full life cycle, issues management. * Coach and train assigned study teams including internal and external resources to increase risk-based monitoring competence. * Summarize and present the insights identified by the RBM tool for cross-functional teams and assist on identifying relevant intervention strategies. * Facilitates the monthly Central Study Risk Monitoring Review meeting for all studies * Support the life cycle and change management expectations for the RBM Tools to ensure they continue to meet business needs Share: State/ProvincePennsylvania CityKing of Prussia Street Address1020 First Avenue Primary LocationCSL Behring King of Prussia Full Time/Part TimeFull Time Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click below. EEO Statement Share:
The incumbent should have demonstrable clinical development (particularly data management and clinical operations), exercise project management principles and possess risk-based monitoring experience. The CM Lead should comprehend all facets of the protocol and the output from risk identification and assessment. Critical thinking skills are necessary to define and analyze data from complex, overlapping domains to make well-supported decisions. The CM Lead must be able to see the bigger picture that enables identification of trends or outliers so he/she can target specific issues of importance for focused debate. Familiarity with Xcellerate is preferred.
Associated topics: administrative assistant, administrative coordinator, administrative support, associate, document, front desk, operational support, operations director, staff, support
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.