Senior Manager, Data Management

📋 Description

• • Lead and manage data management activities for assigned products, product candidates, and clinical trials across all phases (Phases 1–4) in a neuroscience-focused biopharmaceutical environment.
• • Collaborate with Clinical Sciences, Biostatistics, Clinical Operations, and other cross-functional teams to design clinical trial databases, including CRF development, database validation, and data review tools compliant with ICH/GCP guidelines and regulatory requirements.
• • Oversee external data management vendors, monitoring key performance indicators, deliverables, timelines, and budgets; participate in vendor selection and contract evaluation.
• • Optimize data collection processes by reviewing protocols for cross-trial consistency and identifying standardized case report form modules to improve efficiency and data quality.
• • Support the creation of SDTM datasets, including oversight of external vendors responsible for data transformation and validation.
• • Maintain current knowledge of data management regulations, Health Authority requirements, and industry trends to provide strategic input and recommendations.
• • Propose, draft, and maintain Standard Operating Procedures (SOPs) and other departmental policies related to data management practices and systems.
• • Participate in the selection and implementation of data management systems and technologies to enhance operational effectiveness.
• • Perform hands-on data management tasks including database cleaning, generating patient-level listings, and reviewing safety laboratory data and adverse event/medication dictionary coding.
• • Ensure compliance with company policies, including the Code of Business Conduct and Ethics, and regulatory standards throughout all data management activities.
• • Travel up to 10% domestically and internationally to support clinical trial operations, vendor meetings, and cross-functional collaboration.
• • Work from Xenon’s Vancouver, BC office with a minimum of two onsite days per week; remote work is permitted for the remaining days.
• • Act as a key member of the Clinical Development team, fostering collaboration with internal stakeholders and external CRO partners to ensure timely, high-quality data delivery.
• • Apply scientific and data-driven approaches to problem solving while demonstrating creativity and flexibility in addressing complex data management challenges.
• • Contribute to the advancement of Xenon’s pipeline, including Phase 3 programs for azetukalner in epilepsy, major depressive disorder, and bipolar depression, as well as early-stage candidates targeting Nav1.7 and Kv7 ion channels.
• • Support the upcoming FDA New Drug Application submission for azetukalner in focal onset seizures scheduled for Q3 2026 and international regulatory submissions supported by X-TOLE3 and X-ACKT studies.
• • Leverage expertise in CNS, pediatric rare disease, and e-diary database design to enhance trial data quality and operational efficiency.
• • Build and maintain credibility and trust across teams through strong leadership, interpersonal skills, and conflict resolution capabilities.
• • Contribute to a culture of inclusion, collaboration, and productivity aligned with Xenon’s values as a premier neuroscience company.