Clinical Process Coordinator

hace 2 días

Ciudad de México IQVIA A tiempo completo

**Clinical Process Coordinator, cFSP****Hybrid role (Mexico City)**Job OverviewLeads and oversees the execution of clinical projects and research studiesProvide project related assistance for all assigned project(s), sites and project teams. Ensure all work is conducted in accordance with SOPs, policies and practices, in accordance with global and local regulations to best meet customer needs while working toward organizational goals and strategies.Provides project-related support to the project management teams of assigned clinical research studies. Establishes and maintains all project documentation; conducts technical reviews and audits of files for accuracy and completion; tracks key communications and documents; and maintains internal systems and databases.Essential Functions:Includes but not limited to:- Support in ensuring compliance with contract, SOPs, GCPs, policies, and regulatory- Support in meeting quality & timeline metrics- Assist study manager/ study lead in effective management of eTMF and its Inspection Readiness- Establishment and maintenance of Study in Gilead's Global Clinical Trials Management System (GILDA)- Weekly reports and updates, dashboard management- Assist the Study Lead in preparing reports and trackers to track various metrics (electronic data capture report, action items, Protocol deviations etc)- Perform access management for the study team- Support the clinical project team by accurately updating and maintaining clinical systems within project timelines.The CPC works in partnership with the Study Lead and the Study Process lead (CL) providing support with project management activities to mitigate risk, control cost, manage project schedule, and ensure customer satisfaction related to assigned project/s.**Qualifications**:- Bachelor's Degree Life sciences or other related field Req- Typically requires 0 - 2 years of prior relevant experience.- 1 year of relevant clinical research experience with analytical/financial skills or relevant Project Management experience or equivalent combination of education, training, and experience.- GCP Course will be highly valued- Advanced English level- Excellent Communication and interpersonal skills.- Excellent Problem solving and Organization skills- Attention to detail skills.

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