Senior Lead Clinical Data Manager

at  Advanced Clinical

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
  At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Clinical in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.

• 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