Senior Lead Clinical Data Manager

The Senior Lead Data Manager ("LDM") serves as the primary point of contact for data management and is responsible for oversight of all data management activities for their assigned studies. The Senior LDM will be assigned to complex studies and is expected to oversee the work of all other data management team members assigned to their studies.

Responsibilities :

• Follow departmental and company procedures with quality
• Coordinate and ensure the accuracy and completeness of all data management activities; including oversight of assigned study team member activities and external vendors
• Serve as the study project manager for biometrics stand-alone services
• Conduct and participate in meetings as applicable for the scope of work, representing data management services for assigned studies
  
  
  1. Facilitate cross-functional meetings for biometrics stand-alone studies
  
  
  
• Present at study kick-off meetings, investigator meetings, client meetings, etc.
• Author and maintain all study start-up documents; including, but not limited to eCRFs, Data Management Plan, Edit Check Specifications
• Review and finalize documents developed by other data management team members such as the eCCGs, Data Transfer Specifications, etc.
• Facilitate and participate in all study start-up activities; including eCRF development, database programming, user acceptance testing, study start-up documentation, supplemental module setup/integration (i.e, RTSM, ePRO) etc.
• Maintain the study database for assigned studies; drive all required mid-study update activities
• Create and maintain study timelines
• Author all database lock documentation for assigned studies
• Oversee all data management activities; including discrepancy management, reconciliation, coding, listing/report programming, metric reporting, local lab handling, archival etc.
• Ensure completion and accuracy of data transfer specifications; coordinate the receipt of data transfers
• Ensure awareness of and adherence to the contracted scope of services for assigned studies; identify change orders
• Provide input on monthly financial reporting for assigned studies
• Participate in business development meetings, presenting data management in proposals
• Prepare all database lock documentation
• Ensure the completeness of the trial master file
• May participate in department initiatives and process improvements
• May participate in the development and revision of department SOPs
• May serve as subject matter expert
• May provide training and mentoring for other Lead Data Managers
• Perform other duties as requested by management

Qualifications:

• Bachelor's Degree preferred, equivalent combination of education and relevant experience may be considered
• Working knowledge of clinical research best practices preferred
• Excellent oral and written communication skills, organizational skills, and attention to detail are required
• Minimum of 4 years direct data management experience in pharmaceutical development, CRO, or clinical research environment; with at least 1 year in a direct lead data manager role