Clinical Data Management

Vendor Oversight 

Mainly focused on CRO oversight and ensuring delegated DM and CDMS-related tasks are executed with excellence and within budget/timelines 

  • Fully integrate into Sponsor team as their primary or supporting representative for all deliverables related to data management and the CDMS 

  • Partner with Sponsor to ensure the CRO products align with protocol requirements, best practices and team goals/decisions (“fit for purpose”) 

  • Manage, or assist in the management of, the CRO’s performance related to quality, timeliness and adherence to study documentation (DMP, data review/validation, etc.) 

  • Lead the review of all data management and CDMS-related documentation 

  • Act as the primary resource for User Acceptance Testing planning, execution and documentation 

  • Communicate risks to the internal Sponsor team as they develop and provide mitigation strategies for approach and resolution 

  • Monitor applications for workflow alerts, system errors, performance issues and troubleshoot matters as they arise

Data Management Leadership and Support 

Act as a Data Management Oversight, Lead Data Manager, or a supporting member of the larger data management team to properly execute the day-to-day activities  

  • Budget review and input, with Clinical Operations in support 

  • eCRF design and specification development 

  • Document creation and maintenance – Data Management Plan, eCRF Completion Guidelines, User Acceptance Testing Plan, Data Transfer Agreements, Data Validation Plan, etc. 

  • Metrics reporting - Weekly performance metrics, Clean Subject Reports, custom Missing Pages Report, etc. 

  • Data Review and Cleaning, in accordance with the Data Review/Validation Plan - Query resolution, manual data listing review, coding review facilitation, external data reconciliation (Data Transfer Agreements, reconciliation report specs and UAT, reconciliation review/cleaning and documentation) 

  • User Administration and reporting - Sites, monitors, sponsor, CRO, vendors, etc. 

  • Support Data Visualization reporting