Associate Data Team Lead

Detalles de la oferta

**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


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

Requisitos

Analista De Data

La Empresa más reconocida en Latino américa en manufactura, distribución, y comercialización de herramientas y productos para todos los segmentos de la indus...


Truper - Tamaulipas

Publicado 9 days ago

Business Analyst

Alinsco Insurance is the top auto insurance agency in Texas in customer service, catastrophe management, and claims processing. Currently we are looking for ...


Alinsco Mexico Sa De Cv - Tamaulipas

Publicado 8 days ago

Qa Analyst / Test Analyst

Excellent communication skills (written/verbal) to interact with users, developers, business analysts, and IT Management.- Analyze documentation and technica...


Edgar Baker Mexico - Tamaulipas

Publicado 8 days ago

Business Analyst

.Join a company whose mission is to support modern businesses in their quest to grow fast and flexibly. We achieve this by offering innovative services deliv...


Alliance Virtual Offices - Tamaulipas

Publicado 8 days ago

Built at: 2024-12-12T16:23:17.321Z