Data Management Operations Lead

By acting as the primary Data Management (DM) representative to the study management team, the DM Operations Lead partners with Data Management Portfolio Lead and key study/program team members to develop and implement project plans for assigned studies, ensuring the functional activities are completed by vendors according to specified quality standards and timelines, and for coordinating ongoing data management activities with vendors to support the flawless execution of a clinical trial. May support special initiatives both inside and outside the Data Management department. Uses phase, TA and operational knowledge to establish and implement study level operational plans and oversees vendors to ensure on time project delivery on all assigned projects. Develops study level quality/oversight plans and ensures adherence and consistent execution across the data flow. Collaborates with DM Portfolio Leads to ensure alignment of study operational plans with program goals. Contributes to and/or accountable to update and manage study dashboards, timelines, resource prioritization, and data deliverables.

• Accountable for development of timelines, project management of all end to end data management deliverables in collaboration with cross functional team members and vendors on assigned studies
• Single point of contact for the execution of data management deliverables on assigned trials/programs. Interprets and applies data strategy, ensures use of global/program standards, coordinates and oversees outsourced personnel, and monitors and reports on overall study progress.
• Accountable for overall consistency of DM standards across assigned trials/program and quality/integrity of the data. Ensures high utilization of standards library components (e.g. eCRFs, Edit checks)
• Develops risk mitigation or action plans and oversees execution when appropriate.
• Reviews performance metrics and trends for DM deliverables on assigned studies/programs and ensures most optimal execution. Reports/Escalates issues/risks to Portfolio Lead.
• Primary contact between DM and clinical study management teams (SMT). Liaises directly with internal customers (Biometrics functions, Clinical, Medical, Regulatory Affairs) and external customers (Full Service and Functional Service Provider Data Leads and Project Management personnel)
• Contributes to the development of DM process, data collection and management, reporting, and process improvement and innovation as needed
• Manages performance and quality issues with vendors (FSP and 3rd party data providers such as labs) and escalates to DM Portfolio Lead, DM management. Develops appropriate risk mitigation, as needed Support study-level/drug program audit and inspection readiness activities as needed
• Supports special projects and initiatives; partners with Statistical Programming, Biostatistics, Vendor Management, and Quality as well as Global Development depending on type of project.
• 8+ years relevant work experience with a focus on clinical data management, 4+ years as a Trial Data Manager with full accountability across study start-up, conduct, and lock.
• Robust experience with Medidata Rave and use of Data Review tools such as

The Data Management Operations Lead manages the end to end clinical data flow (data acquisition from Case Report Form (CRF) development to Clinical Study Reporting (CSR) of Clinical Data) and ensures timely project execution, quality data deliverables, and prioritization of all DM milestone delivery. Recognized as an operational specialist in clinical data flow and study execution by all functions across Global Development.