Vacancy expired!
- Applies critical thinking to ensure real-time inspection readiness of clinical documentation by: - investigates and proactively resolved issues - runs and performs review of reports and dashboards within eTMF - produces eTMF metrics - communicates to Master File owner(s) analysis and potential data integrity concerns
- Leads to completion of the final reconciliation/review and archival of individual master files, working closely with the Clinical Documentation Associate (CDA), CDC leadership and other TMF stakeholders (i.e., CPD, DSS, BSO).
- For CRO managed study TMFs: conduct QC of artifacts (may also include uploading and classifying); involvement with transfer of CRO TMFs into AbbVie eTMF system
- Provides audit and inspection preparation support for paper and electronic TMFs, to include, but not limited to (on selected master files): - conduct data integrity checks - run & analyze reports for TMF completeness - work with the assigned CDA to follow-up on outstanding items with other functional areas - contribute to completion of pre-inspection requests
- During an inspection: - function at the subject matter expert of the eTMF system navigation, including being present in the with the Auditors/Inspectors - participate in responding to auditor/inspector requests (may be required to put the response together)
- Conduct TMF conversion activities; involvement with the transfer of TMFs from external entities (i.e., CRO, other pharmaceutical companies).
- Review regulatory documents / packages for approval of Investigational Product (IP) release and work with Artifact Owner(s) to correct errors. Provide approval for release of IP to investigator sites.
- Provides suggestions for CDC work instructions/job aides and contributes to functional area continuous improvement projects and/or work streams.
- Complies with GCP, AbbVie SOPs and functional area processes.
Vacancy expired!