Principal Clinical Data Manager
Inno Clinical Outcomes Llc (Name Change To Aperio Clinical Outcomes Llc)
• Manages a data management project• DM lead for internal/client team meetings and communication• Produces and reviews metric reports for internal/external project team• Ownership for project deliverables within DM scope of services including projections• Identifies roadblocks and provides solutions for completing project objectives in a timely manner• Reviews project budgets and staffing projections for data management activities• Provides training of other DM staff on project specific processes• When required as a single service contract, manages project financials and project management activities• Clinical Data and Query Review• Creates the Data Review Plan and the DM listings using ad hoc query tools• Issues queries and reviews query responses with the highest level of quality based in accordance with the Data Review Plan/Guidance document; including Manual Review (AE/CM comparison, Inclusion/Exclusion review, etc.), and Reconciliation (LAB, SAE, ECG, and other vendors)• Oversees System Development and Modifications:• Drafts the CRF design, edit check specification and DM listings• Facilitates clinical team review of system documents (CRFs, Edit Checks, Data Review Plan, etc)• Manages all database build and modifications (expectations for timelines, UAT, production release)• Creates and Maintains Documentation for the project• Data Management Plan, CRF Completion guidelines, Data Entry guidelines, Edit specifications, Reconciliation guidelines, and Report specifications• Database release documentation (blank CRFs, annotated CRFs, edit checks, configuration/workflow)• Project Specific SOPs/WPs (as directed by PM)