The Manager, Data Management is responsible for managing all aspects of data management activities and assigned direct reports to ensure all time frames and targets are met. The Manager, Data Management may serve as portfolio level oversight or as Biometrics Project Manager for data management and biostatistics stand-alone programs.

Responsibilities:

• Onboarding of new employees; including training on data management procedures and systems
• Mentor, monitor and supervise direct reports (including monitoring time reporting and training requirements)
• Responsible for the hiring, promotion, transfer and release of staff
• Conduct performance reviews and assist with goal setting of direct reports
• Provide input on resource planning and assignments
• Project budget oversight; including revenue recognition, forecasting, billing, invoicing and change orders
• Identify and manage project risks
• Participate in data management candidate interviews
• Implement and maintain performance metrics
• May facilitate department meetings
• Coordinate and ensure the accuracy and completeness of activities for assigned oversight studies
• Create material and present at study kick-off meetings, investigator meetings, client meetings, etc.
• Review and ensure the quality of data management documents; including, but not limited to: eCRFs, eCRF Completion Guidelines, Data Management Plan, Edit Check Specifications
• 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
• 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

Qualifications:

• Minimum of 6 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
• The ideal candidate will have 2 years of management/leadership experience, but is not required
• Good knowledge of medical terminology and conduct and analysis of clinical trials
• Knowledge of relevant industry data standards (e.g. CDISC, CDASH)
• Excellent oral and written communication skills, organizational skills, and attention to detail are required

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research - approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.