Clinical Trial Monitor

Detalles de la oferta

.At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.Responsible for the oversight of the progress of a clinical trial and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable regulatory requirement(s).Act as one of the points of contact at a Site level for internal and external stakeholders.Identifies new potential Investigators, through ongoing collaborations with internal and external stakeholders.Assesses potential Investigators and their sites to ensure they have the resources and capabilities to conduct clinical trials.Develop Site relationships (incl. Contract Research Organization related issue management and non- registrational /Investigator Sponsored Research Studies)Recommends sites during the site feasibility and/or site selection processConducts pre-study visit as appropriateConducts initiation visits to ensure Investigator and site personnel receives adequate protocol specific training prior to site activationPerform Unblinded Site Monitoractivities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor.While monitoring demonstrates the ability to use data to assess risks, identify issues and make appropriate decisions.Serve as a point of contact for SitesProvides trainings to sitesPerforms site closure activities when all required protocol visits and follow-up are completedManages multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.Ensures completeness and quality of data submitted from study sites. Ensures eCRF data is available and current by using the available systems to follow site activities.Oversees activities of site personnel over whom there is no direct authority.Motivates/influences the site to meet study objectives, including enrolment and retention goals. Demonstrates flexibility and adaptability when communicating with different stakeholders utilizing the most appropriate communication methodAnticipates, identifies and proactively supports site in resolving issues as they occur. Appropriately documents and promptly escalates serious or persistent outstanding issues to management and project team. Initiates, recommends, documents and communicates corrective actions as needed and follows up to ensure corrective/preventive actions based on root cause analysis are implementedInvolvement in Regulatory Compliance audit/inspection process, as needed


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

Requisitos

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Operator C | Ecoson | 5 Ploegen | Son | €3380 – €4550

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