Clinical Research Associate I
1 dia atrás
**Summary**:Site relationship management role to ensure sustainable trial execution at Site.Performs on-site and remote monitoring activities related to initiation, conduct and timely completion of Phase I-IV GDD trials within the country in adherence with monitoring procedures and processes in accordance with ICH/GCP, local regulations and SOPs.Proactive site performance management (recruitment & quality) and early identification of real site needs and issues as the single best point of contact (internally & externally) for all sites.(from issue management to risk identification).**About the Role**:**Major accountabilities**:- Conducts continuous site monitoring activities (onsite and remote) and manages assigned study sites, conducting phase I-IV protocols.Implements site management activities to ensure compliance with protocol, ICH/GCP, global and local regulation including Health Authorities, IRB/EC, data privacy requirements, global and local processes as applicable.Documentation according to GDP and Novartis standards.- Performs Site Initiation Visit and Site Closeout activities per SOPs and applicable regulations.- Frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliverables with true ownership mindset.- Establish a strong partnership and true collaboration with the site, to increase patient density and decrease issues at site.- Early engagement with site on patient inventory and patient flow in advance of SIV in close collaboration with global and local study team- Proactively collaborates with the SSO Clinical Project Manager (CPM) and CRA Manager as well as MSL, CRMA and medical advisor to ensure optimal recruitment, site development and data quality.- Participates in audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines.- Ensures the site Investigator Folder is up to date.Responsible for collecting essential documents from site and accountable to keep sTMF(s) up to date.**Key performance indicators**:- Next level of site collaboration measured by patient density at site, achievements of commitments and targets and deliver customer satisfaction results.- Meets study milestones.- Ensures the delivery of high-quality data according to agreed timelines with adherence to prevailing legislation, GCP, Ethical Committee and SOP requirements.- Quality and timeliness of updating the Novartis systems, monitoring reports, and communication efforts as defined by global KPIs and KQIs**Minimum Requirements**:**Work Experience**:- Degree in scientific or healthcare discipline- Field monitoring experience- Operations Management and Execution.- Up to 2 years pharmaceutical industry experience or other relevant experience- Collaborating across boundaries.**Skills**:- Clinical Monitoring/Research/Trials.- Fast change adaptability.- Collaboration.- Data Integrity.- Decision Making Skills.- Ability to travel.- Good communication skills- Ability to manage sites independently- Time management and organization capabilities**Languages**:- English (Written and Spoken).DivisionDevelopmentBusiness UnitInnovative MedicinesLocationBrazilSiteSanto AmaroCompany / Legal EntityBR03 (FCRS = BR003) NOVARTIS BIOCIENCIAS S.AFunctional AreaResearch & DevelopmentJob TypeFull timeEmployment TypeRegularShift WorkNo
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Clinical Research Manager I
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Clinical Project Manager
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Sr. Field Medical Lead
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