Clinical Data Review Systems-Senior Manager

Role Summary

Clinical Data Review Systems-Senior Manager. Lead data review strategies and provide strategic direction to ensure successful delivery against clinical programs, leveraging best-in-class data science practices within a cross-functional environment.

Responsibilities

• Manage multiple therapeutic areas and cross-functional initiatives
• Oversee technology evaluations and implementations for performance improvement and cost reduction
• Create and sustain an environment that attracts, develops, and retains strong talent
• Practice continuous improvement of processes and technology usage
• Act as subject matter expert and process owner
• Supervise and allocate internal and external resources within the Therapeutic Area
• Ensure performance assessment responsibilities are achieved for direct reports; provide training, feedback, and talent retention for assigned staff
• Responsible for performance management of staff; support building and maintaining a high-performing team, recruitment, onboarding, resource assignment, and development opportunities
• Manage cross-functional initiatives
• Provide strategic direction, advice, and guidance to staff on operations responsibilities and activities; promote best practices and ensure objectives are met

Qualifications

• Bachelor’s degree in management information systems, computer science, life sciences or equivalent; Master’s preferred
• 8+ years of experience with clinical database design, data loading, and database modeling concepts, or 9+ years in a similar technical or clinical development environment
• Demonstrated intermediate SAS and/or SQL programming skills and expert knowledge of database concepts
• In-depth knowledge of CDASH and SDTM Standards; strong understanding of clinical trial processes
• Demonstrated ability to influence others without direct authority; track record as a key contributor to initiatives; ability to coach/mentor in a matrix environment; strong communication and analytical skills

Skills

• Clinical data management
• Data modeling and database concepts
• SAS/SQL programming
• Process improvement
• Stakeholder influence and leadership
• Cross-functional collaboration

Education

• As listed in Qualifications