Senior/Clinical Data Coordinator

Detalles de la oferta

**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 preferredLI-Remote


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

Requisitos

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