Senior/clinical Data Coordinator
hace 2 meses
**Job Overview**
The Sr. Clinical Data Coordinator performs activities related to the conduct of Phase I - III clinical trials in accordance with ICH/Good Clinical Practices (GCP) and other relevant procedures and guidelines. This role ensures that quality work products are produced, and timelines and deliverables are met. **This position can typically be a support lead role with 3 to 5 years of Clinical Data Management (CDM) experience, particularly with Oracle and Inform tools.**
**Essential Functions**
- Perform ongoing data review, including reconciliation of third-party data streams and serious adverse event (SAE) reconciliation with the safety database.
- Conduct User Acceptance Testing (UAT) of clinical databases.
- Perform Quality Control (QC) of clinical databases.
- Update Data Management-related documentation as needed.
- Work independently on discrepancy management and listings review.
- Send Data Management (DM) metrics to the trial team.
- Handle third-party data reconciliations such as Lab, PK, IRT, and SAE recon.
- Participate in startup activities, mainly in conduct and close-out activities.
**Qualifications**
- Bachelor’s degree
- Minimum of 3 years of data management experience is required.
- ** Experience with Electronic Data Capture (EDC) systems is required.**
- Experience with Oracle Inc.'s Inform EDC system is preferred.
- Oncology and/or inflammatory therapeutic area experience is preferred.
- Experience in working independently on discrepancy management, listings review, and handling third-party data reconciliations.
- Experience in startup activities, particularly in conduct and close-out phases, is preferred
LI-Remote
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