Associate Director, Clinical Data Management

Key Responsibilities

• Lead all data management activities from study start-up through final database lock for multiple programs
• Create and track timelines for Data Management activities
• Create and maintain the Data Management Plan
• Develop and design Case Report Forms (CRFs)
• Develop Database Build specifications
• Lead and execute Database Build and testing activities
• Define, build, and test edit checks
• Perform data review and query generation/resolution
• Process/reconcile electronic data received from other data sources, Safety database, labs, etc.
• Database lock and transfer process
• Track project progress and issue status reports to ensure the achievement of key Data Management milestones, such as database Go-Live and completion of tasks towards Database Lock
• Cook up and execute coordination of the work of CRO staff assigned to the project
• Ensure approved study documentation is maintained and properly stored in the trial master files
• Develop or assist with the project training development and delivery, for investigators, clinical sites, project teams and CRO on data collection processes, tools and/or equipment as required
• Act as point of escalation for data related issues and queries
• Contribute to the continuous improvement of DM and the wider organization through information sharing, training and education

Qualifications

• BA/BS degree required
• 7-10+ years of experience in clinical research, drug development, or other healthcare environment, including 5+ years of experience in data management
• Proven track record of oncology data management excellence with a focus on quality and matrix team environments
• Excellent teamwork, communication (verbal and written), organizational, and interpersonal skills
• Self-motivated, proactive, and able to prioritize and manage multiple initiatives simultaneously
• Led or participated in leadership / mentoring experience