Manager, Clinical Data Management

Primary Responsibilities And Job Functions

• Represent DM as the functional lead at study team meetings; responsible for communication and collaboration, assuring overall quality of study data
• Assumes ownership for DM study deliverables within DM scope of services including overseeing overall quality, adherence to Study Plans and standard operating procedures & creation and management of DM-specific timelines
• Data Reconciliation (e.g., Vendor, SAE) including coordination of transfers and issue resolution with other functional areas and/or 3rd party vendors
• Investigation and remediation of reviewer-reported data issues such as from statistical, safety, clinical or medical reviews
• Covers with ProKidney, CRO and other 3rd party vendors to develop and maintain DM startup timelines including the development, UAT testing and implementation of all data capture tools
• Covers with ProKidney, CRO and other 3rd party vendors to manage post-production EDC modifications assuring effective implementation (including consistency across program when applicable) and team communication for program and/or projects
• Develops, Maintains, Reviews, Approves and Archives DM Project Documentation including: Case report forms, edit check specifications, Data Management Plan, Data Review Plan, CRF Completion Guidelines, and other study-specific plans as required
• Data review listing specifications and data transfer specifications
• Ensures quality check of clinical data as appropriate for statistical review, interim review, and or final database lock. Responsible for database lock, close-out audit and archiving activities
• Manages and stores data transfers from 3rd party vendors
• Develops and manages patient profiles for clinical review and data cleaning

Minimum Requirements

• Must have undergraduate degree and 4-6 years of industry experience

Skills/Abilities

• Proven ability to meet strict deadlines
• Manage competing priorities and ability to be flexible and receptive to changing demands
• Excellent organizational skills and time management skills
• Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint)
• Proven ability to follow instructions/guidelines, work independently and on own initiative
• Excellent attention to detail and accuracy maintaining consistently high-quality standards
• Excellent written/verbal communication and report writing skills
• Sound judgment, independent thinking, and decision-making skills
• Self-motivated and flexible
• Able to establish and maintain effective working relationships with coworkers, managers and clients
• Good understanding of operational metrics, productivity and initiatives
• Demonstrate effective project management skills
• Knowledge of global standards related to clinical data management activities