Senior Manager, Data Management

About the role

The Senior Manager, Data Management leads clinical data management activities for multiple clinical studies and/or a clinical development program. They oversee CRO partners, ensure data quality and integrity, and contribute to operational improvements.

Responsibilities

• Oversee Clinical Data Management activities outsourced to CROs
• Develop Data Management metrics and KPIs
• Ensure CRO adherence to project timelines
• Collaborate with clinical study teams and vendors
• Review data for performance and quality
• Contribute to the development of Data Management processes, policies, and SOPs
• Lead data management study inspection readiness activities and submission activities
• Train and mentor Data Management staff
• Perform hands-on data management responsibilities, if required

Qualifications

• Bachelor’s degree in a science-related discipline
• 6+ years working in clinical data management at a Sponsor organization
• Experience across multiple indications and EDC platforms
• Extensive knowledge of clinical data management outsourcing models
• Advanced hands-on knowledge of data management processes and EDC systems
• Knowledge of regulatory requirements (e.g. ICH, GCP, HIPAA)
• Experience with data visualization, analytics, and reporting tools
• Strong project management skills
• Ability to solve complex problems independently
• Effective written and verbal communication skills
• Self-motivated, reliable team member
• CDASH experience
• Initiative, sound judgment, and flexibility

Skills

• Knowledge of clinical drug development processes
• Experience with data management processes and EDC systems
• Regulatory requirements (ICH, GCP, HIPAA)
• Data visualization, analytics, and reporting tools (elluminate or SpotFire)
• Project management skills
• Ability to work independently and manage multiple projects
• Written and verbal communication skills
• Team player
• Ability to influence without authority

Pay

$135,000 - $215,000

Schedule

Hybrid work model with occasional travel