The Senior Lead Data Manager (“Lead”) will have experience in all required areas of a Lead Data Manager. The Lead is responsible for the data management project oversight resulting in quality and accuracy of the database for a clinical study. The Lead is the primary data management contact for the project and may also coordinate the work across multiple projects for a client program.

ESSENTIAL FUNCTIONS:

• Exceed expectations and responsibilities of a Lead Data Manager
• Serve as primary point of contact for data management projects
• May serve as Biometrics lead for stand-alone studies including data management and biostatistics services
• Coordinate and ensure the accuracy and completeness of activities for data management assigned study team members
• Create material and present at study kick-off meetings, investigator meetings, client meetings, etc.
• Author and maintain all project start-up documents; including, but not limited to: eCRFs, eCRF Completion Guidelines, Data Management Plan, Edit Check Specifications
• Perform/provide oversight of user acceptance testing for assigned projects
• Create and maintain project timelines
• Prepare data transfer agreements & coordinate the receipt of data transfers
• Author all database lock documentation for assigned projects
• Prepare all data cleaning and data status documentation; including, but not limited to: metric reports, custom reports, data review listings, reconciliation reports, clean patient tracker, etc.
• Responsible for project budget oversight, revenue recognition, forecasting and billing/invoicing review/approval
• Serve as subject matter expert
• Provide training and mentoring for other Leads and Clinical Data Associates
• Proactively monitor scope of work to actual work, alerting management of potential change orders or resourcing needs
• Standard Operating Procedures (SOPs)
  • Strong understanding of departmental and company procedures; ability to guide others on procedures
  • Participate in the development and revision of department SOPs
• Business Development
  • May support the business development process; RFI completion, proposal development, bid defense participation, attendance at industry/scientific meetings, etc.
• Additional Responsibilities
  • Perform other duties as requested by management
  • Participate in data management candidate interviews

QUALIFICATIONS:

• Minimum of 5 years direct data management experience in pharmaceutical development or CRO environment
• Bachelor’s Degree preferred. Work experience may be substituted for degree
• Working knowledge of CDASH standards
• Excellent oral and written communication skills, organizational skills, and attention to detail are required