Associate Data Team Lead

hace 6 días

Desde casa, México IQVIA A tiempo completo

**Job Overview**The Clinical Data Manager (CDM) is responsible for managing data activities for Phase I-III clinical trials, ensuring compliance with ICH/Good Clinical Practices (GCP) and other relevant guidelines. The CDM ensures trials are completed on time, within budget, and with the highest quality.**Key Responsibilities**:- Serve as the primary data management representative on multidisciplinary project teams.- Communicate key clinical data management metrics (e.g., data entry status, query resolution, and aging) and determine appropriate actions with the study team.- Review, develop, and write clinical trial documents and manuals, including Case Report Forms, Edit Checks, Data Management Plans, Clinical Data Review Plans, and eCRF Completion Guidelines.- Participate in User Acceptance Testing (UAT) and Quality Control (QC) as needed.- Collaborate with Clinical Database Programmers to develop Data Flow Charts, Data Transfer Specifications, and Import Guidelines.- Assist with training sites and third-party vendors on CDM-related topics.- Provide data review training and guidance to Senior Clinical Data Coordinators supporting the trials.- Perform data review and discrepancy resolution as needed.- Archive trials and associated documentation upon completion.- Ensure adherence to Good Clinical Practice and all applicable local and international regulations.**Qualifications**- Minimum of 4-6 years of data management experience, with 2-3 years of leading studies independently preferred.- Experience from startup through database lock, with at least 2-3 startups and 2-3 database locks.- Experience with Oracle Inc.'s Inform EDC system is preferred.- Oncology and/or inflammatory therapeutic area experience is preferred.- Project management experience within Data Management is preferred.- Experience with Electronic Data Capture (EDC) systems is required.- Bachelor’s degree but individuals with commensurate experience will be considered.- Work history at a Clinical Research Organization (CRO) or CRO management experience in data management is preferred.LI-Remote

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