Senior Manager, Clinical Data Management - Clinical Trials (Remote)
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About The Position
The Senior Manager, Clinical Data Management is responsible for ensuring timely and high-quality data management deliverables that support Walgreens Clinical Trials studies. This role involves conducting oversight of Data Management activities to ensure compliance with the International Council for Harmonisation - Good Clinical Practice (ICH-GCP) and the project Scope of Work. The Senior Manager will provide data management expertise and capabilities in support of submission studies, as well as post-marketing registration and non-registration studies. In this position, the Senior Manager will lead data management activities for customer studies and serve as the subject matter expert (SME) and owner of data management plans. They will oversee the creation and maintenance of study databases, including industry-standard Electronic Data Capture (EDC) systems such as Medidata Rave, Veeva Vault EDC, and Viedoc. The Senior Manager will also provide input to functional governance with Walgreens vendors and partner with team members to resolve issues escalated from vendors and teams. The role includes leading clinical trial data collection set-up, data review, and database lock processes. This involves working with vendors to complete the setup of EDC and other study data collection tools, leading the creation and maintenance of study data cleaning plan components, and managing data review activities, including query management. The Senior Manager will participate in preparing functions for submission readiness and may represent the function in formal inspections or audits. They will ensure the archival and inspection readiness of all Data Management Trial Master File (TMF) documents and secure functional resources to support all studies within scope. Additionally, the Senior Manager will maintain standard operating procedures (SOPs), process maps, and templates to support operational and oversight models, and may prepare metrics to support the function's key performance indicators (KPIs). The Senior Manager will also represent the function in external professional projects and organizations to identify industry best practices, ensure the quality of data in each database delivery, and provide functional oversight to data management and other clinical trial team members. They will champion and adopt technology improvements and tools for use in clinical data management processes.
