Job Summary
The incumbent is responsible for effectively participating in the start-up and completion of multiple Data Management projects according to stakeholder requirements and in accordance to SOPs and other applicable standards in compliance with Sun Procedural Documents, ICH-GCP and local regulations
Area Of Responsibility
- Effective management of all data management aspects of assigned project(s) from setup to lock.
- Attend regular meetings with project team, for discussions relating to data management issues and provides status updates for the project.
- Report on quality and performance metrics, including timelines, to project leads and other stakeholders
- Participate in in-house and external training courses, where required.
- Participate in the preparation/review of Data Management process control documents, including but not limited to Data Management Plan, Data Edit Checks Specification, User Acceptance Testing, Data Transfer Agreements/Specifications, Reconciliation plans, CRF Completion Guidelines, Coding Guidelines, etc.
- Coordinate and manage training and EDC access for investigators, coordinators, data entry and CRAs on selected applications for data entry, cleaning, and running reports, as applicable to study parameters.
- Review, freeze and/or lock data in accordance with Data Management documents for accuracy, completeness, consistency and validity, generate queries, as necessary, for sites and/or project team.
- Coordinate with Medical Data Reviewer and/or Medical Monitor for the coding of medical terminology, as required.
- Maintain Data Management study documentation in an audit-ready status,
- Perform reconciliation, including but not limited to SAS/AE, Electronic Data Files (EDF) and third-party data such as central labs and IVR, against the clinical database and track issues to resolution.
- May present at investigator meetings and PM/CRA training sessions.
- Identifies and recommends process improvements to management team, as identified.
