The Manager of External Data Management is responsible for the delivery of external data. This role involves collaboration with Clinical and Medical teams, Functional Stakeholders (such as QCP and Clinical Biomarkers), Clinical Safety, CROs, and External Vendors to support drug development processes and global submissions. This position provides data management expertise by partnering with both internal and external stakeholders (including Central Labs, Specialty Labs, Biomarker Vendors, and Companion Diagnostics) to enhance data collection services . Additionally, the role ensures the quality delivery of all third-party data from various external providers for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. The Manager will validate electronically transmitted external data, ensuring that all clinical and companion diagnostics data meet quality requirements and protocol-defined analysis endpoints (primary, secondary, exploratory, etc.).

Requirements include:

• 5 or more years external data management background and strong knowledge of 3rd party vendor management and oversight of external data standards is required
• Knowledge of CDISC and SDTM and industry standard data collection practices
• Experience working with external data and external data vendors (biomarker, PK, ePRO, etc)