OFERTA DE TRABAJO Lead CRA

Lead CRA. Nombre de la empresa: DOCS. Ubicación de la empresa Madrid y alrededores, España. This a great opportunity for a Lead CRA to join an international team within a strategic pharmaceutical company. The Lead CRA is responsible for coordinating and leading the local trial team in order to deliver quality data and trial documents/records that are compliant with assigned protocol, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs) and regulatory requirements. CTM actively contributes to process improvement; training and mentoring of CTAs, CRAs and others CTMs. Role and Responsabilities: Is responsible for country do-ability (if applicable) and site feasibility assessment in conjunction with CTA, CRA and GTM. Implements any local criteria for site selection. Ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report. Recommends suitable sites for selection to participate in trial. Collaborates with other Areas to select final site list. Contributes input to the Trial Plan, Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at a country level or initiates development of these plans for a single country trial. Leads and coordinates local trial team activities in compliance with Clinical Operations SOPs, and applicable regulations. Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. Including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting. Ensures that all SAEs/PQCs are reported within reporting timelines and documented as appropriate. Maintains and updates trial management systems (e.g. CTMS, eTMF/LAF, Trial Master Source anSharepoints). Uses study tools and management reports available to analyze trial progress. Monitors country progress and initiates corrective and preventive actions when the trial deviates from plans and communicates study progress and issues to study management teams. Submit requests for vendor services and support vendor selection. May lead negotiation of trial site contracts and budgets. Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered –within budget. What is required: A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred. At least two years of experience as a Lead CRA. Solid
communication and computer skills required. Proficient in speaking and writing English language. Good written and oral communication skills. TA: All TA and phases. What is Offered: We offer a permanent contract, full time and office based in Madrid. Interesados entrar en el enlace:

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