• Serve as data management lead for multiple products or indications of considerable complexity
• Provide input on vendor and technology evaluation, selection, and performance
• Lead CDM strategies for the assigned area
• Oversee and direct the design and implementation of the CDM process with vendors, including clinical systems design, build and testing, data integration, data review, dictionary coding, data quality checking, data transfer, reporting, and archival activities for EDC, IRT, and other clinical systems
• Review and author technical documents including reports, process descriptions, SOPs, data management plans, data transfer agreements, reconciliation plans, and related documents at the study and department levels
• Provide technical and business process expertise on new and emerging technologies / vendors for clinical trial execution
• Lead and manage a team of direct reports and may manage other people leaders
• Engage in crucial conversations by providing and receiving feedback supporting the growth and development of team members
• Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
• Drive curiosity, scientific rigor, and excellent problem-solving skills across a fast-paced performance driven environment
• Innate ability to assess talent that will help grow the organization and add to Sana’s culture

What we’re looking for

• Progressive experience in clinical data management in the pharmaceutical, biotechnology, or CRO industry of at least 10 years
• Extensive background collaborating with CROs, vendors, and internal study teams
• In-depth knowledge and experience with different clinical systems such as electronic data capture (EDC) systems, IRT and other data collection systems
• Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Sana SOPs and ensures the same across own team
• Broad knowledge and clear understanding of Food and Drug Administration (FDA) requirements related to electronic systems and records; strong understanding of guidelines as they relate to CDM, including Good Clinical Practice (GCP) and International Council on Harmonisation for Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines

What will separate you from the crowd

• Highly competent in clinical data management and use of technology for data capture including data visualization tools

What you should know

• The base pay range for this position at commencement of employment is expected to be between $200,000 and $240,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience