Local Study Manager - Fspx Team - Home Based Madrid

Detalles de la oferta

.As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.This role is for upcoming future opportunities they may arise at Fortrea.The local study manager is accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight, and impact on local regulatory and financial compliance, at a country operations level at the client in compliance with ICH GCP and country regulations. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during the study. As a customer-facing role, this position will build business relationships and represent Client with investigators, functional outsourcing partners and other external partners. Requires ability to make decisions independently and oversee important activities relevant to clinical research activities in the country according to predetermined global policies and commitments with the support, oversight and supervision of the Country Research Director or Therapeutic Director. Requires strong understanding of local regulatory environment, country regulations, client policies and procedures, quality standards. Strong scientific and clinical research knowledge is required for this position.Summary of Responsibilities:PERFORMANCE: Accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally. 30%MANAGEMENT: POC for assigned protocols. Pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments for assigned protocols. Strong collaboration with local CO roles. Forecasts country resource needs. Serves local business needs (signs contracts, manages budgets as delegated). 20%QUALITY OVERSIGHT: Responsible for quality and compliance in assigned protocols in country. Oversees CRAs and CTCs on assigned projects. Oversees training compliance. Performs quality control visits. Reviews Monitoring Visits Reports and escalates performance issues and training needs to functional vendor and internal management as needed. Oversees associate CRMs assigned to the Client and work on training needs in collaboration with functional vendor. 20%EXTERNAL CUSTOMER FACING: Responsible for collaboration with functional outsourcing vendors, investigators, other external partners. Oversees country and site validations, site selection and recruitment in assigned protocols


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

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