looking for a Lead Data Manager. This is a permanent position.
Responsible for the accurate and efficient completion of Clinical Data Management activities on assigned project(s):
•Contribute to and maintain documentation in the project documentation file(s).
•Serve as the Lead Data Manager (LDM) for small, less-complex studies (e.g., Phase I healthy).
Assist the project LDM with:
•Design and content of the Case Report Forms (CRF) and/or CRF Completion Instructions.
•Development of components of the Data Management Plan (DMP) such as annotated CRFs, Data Validation Specifications (DVS), Data Entry Guidelines.
•Perform testing of data entry screens clearly documenting findings to facilitate resolution process.
•Perform testing of edit check specifications clearly documenting findings to facilitate resolution process.
•Create test data for Data Entry Screen and DVS testing.
•Test electronic data transmissions to ensure consistency with specifications and CRF database.
•Independently process clinical data from start-up through database lock prioritizing work to meet project timelines.
•Assist LDM and Senior Clinical Programmer in the development of Data Entry screens, Electronic Data Capture (EDC) screens.
•Perform data review of automated checks and issue queries as required to resolve data discrepancies.
•Perform manual data review as detailed in the DVS and generate well-worded queries to minimize re-queries.
•Review reconciliation listings of electronic data transmissions and issue queries as required to address data discrepancies.
•Report data discrepancies identified and not addressed in study data management documents to ensure that appropriate actions are taken.
•Review data query responses to ensure completeness and accuracy of response relative to other data; update working-copy CRF and database, as required.
•Perform coding of Adverse Events (AE), medications and medical history as applicable, ensuring consistency and accuracy of preferred terms and classifications with similar verbatim terms; issue queries for non-specific/ambiguous terms.
•Perform review of coding to ensure consistency, consult with LDM when necessary regarding discrepancies; make updates accordingly.
•Assist LDM in processing local laboratory reference ranges and reconciling with CRF data.