Summary : Performs tasks in compliance with Standard Operating Procedures (SOPs) / Work Instructions (WIs), regulatory directives, and study specific plans and guidelines.
Performs complex Case Report Form (CRFs) / electronic Case Report Form (eCRF) data review including query creation, closure and requeries as necessary and listing review with increased independence and efficiency.
Performs essential functions which support database development including CRF / eCRF design, data dictionary quality control (QC), user acceptance testing (UAT) and SAS mapping QC, M, Serious Adverse Event (SAE) and external data reconciliations.
Updates the Data Management Plan under the guidance of the Project Data Manager (PDM). Creates and updates the SAE Reconciliation Plan, eCRF Completion Guidelines and provides input into the Data Validation Specification (DVS).
Essential Functions : 1. Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s) and communicates status updates to the Project Manager and / or Biometrics Project Manager as necessary.
2. Reviews and adheres to the requirements of study-specific Clinical Data Management Plans for assigned project(s).3. Updates the Data Management Plan under the guidance of the PDM.
4. Creates and updates the SAE Reconciliation Plan.5. Designs and / or reviews CRF / eCRF including eCRF visit structure co-
coordinating with team members responsible for the associated database design.6. Creates and updates the CRF / eCRF Completion Guidelines.
7. Reviews database design specifications (including configuration, data structures, annotated CRFs).8. Provides input into the Data Validation Specification (DVS) including creation of edit checks for assigned forms including any post-
production updates to the DVS and listings.9. Creates and enters test data for data entry screens for UAT.10. Performs role-
based User Acceptance Testing (UAT).11. Performs UAT of Targeted Source Data Verification (SDV) configuration and matrices.
12. Creates and enter test data for edit checks.13. Enters lab normal ranges.14. Completes and submits CDMS-specific access forms and / or spreadsheets.
15. Performs reviews of discrepancy (edit check) output and validation listings based on data entered into the clinical database.
Based on this review, queries or applies self-evident corrections or other global rulings permitted in cases where queries are not required, per the Data Validation Specification and / or Data Management Plan (DMP) for the assigned projects.
Resolves answered queries and re-queries where appropriate.16. For paper studies, takes receipt of, and reviews, Data Clarification Forms (DCFs) that have been answered by sites and where appropriate, edits the CRF database accordingly.
Submits copies of the DCFs to sponsors as necessary.17. For paper studies, performs internal quality control checks via listing output from database against Case Report Forms (CRFs) and Data Clarification Forms (DCFs).
Serves as QC Coordinator for paper studies.18. For Rave studies, performs DM quality review and / or other internal quality control checks as required per applicable EDC systems.
19. Ensures that data from external databases / datasets such as central and / or local laboratory data, electronic diary data, pharmacokinetic (PK) data, or Interactive Response Technology (IRT) are consistent with data in the clinical database.
Uses the specified process to document and query any such discrepancies found with the appropriate party.20. For paper studies, ensures all Case Report Forms (CRFs) and Data Clarification Forms (DCFs)received are returned for filing in the Document Control Room per the Data Tracking Guidelines for the assigned projects.
21. Creates adhoc data cleaning reports used to determine if a validated listing is required including creation of the specification for the validated listing (updates DVS with the listing requirements).
22. Completes tasks within timeframe by appropriately prioritizing multiple tasks within or across projects and adapts to timeline or priority changes by reorganizing daily workload.
Proactively communicates to project team and management accurate estimates on time to complete tasks, availability to take on new assignments and resourcing conflicts.
Minimizes rework by following study instructions, seeking understanding of assignments prior to performing task and anticipating the effect changes may have on data when issuing and resolving queries.
23. Performs post-migration testing on screens, edit checks, matrices and role changes as required.24. Runs data cleaning and / or status reports.
25. Creates electronic storage media per SOPs for EDC studies.26. Participates in internal meetings and internal / external audits as required.
27. Participates in customer and third party meetings distributing relevant information in advance, ensures minutes are promptly and accurately distributed to internal team for review and subsequent edits are applied in order to maintain established currency for sponsor distribution.
28. Provides project-specific training to other Clinical Data Associates (CDAs).29. Files documentation the Data Management Study File (DMSF).
30. Maintains proficiency in Data Management systems and processes through regular trainings (CDA Knowledge College).#LI-VJ1