Clinical Monitoring Analyst (Cluepoints)

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- RemoteLondon, United KingdomBudapest, HungaryReading, Berkshire, United KingdomBloemfontein, South AfricaDublin, IrelandCenturion, South AfricaBarcelona, SpainSofia, BulgariaMadrid, SpainFull timeRSupports the Centralized Monitoring Lead (CML) in the development of the fit-for purpose CM strategy by contributing to the identification of the relevant CM elements to be implemented for the study (Quality Tolerance Limits (QTL), Key Risk Indicators, data visualizations and Data Quality Assessments)Setup/Program QTL, KRI and Data Quality Assessments according to the study CMPRefresh the Centralized Monitoring Platform at predefined frequency to enable signal identificationGenerate and maintain the Centralized Monitoring Platform specifications document and file it in eTMFReview and understanding of protocol is keyUnderstand the data sources for the study, the data transfer specifications and the data structureExecute and document peer-review of CM platform setup done by other CMA colleaguesExperience:At least 3 years relevant experience in the area of pharmaceutical research and development or related field preferably in centralized Monitoring,



data management, and/or biostatistics2-3 years SAS experience including macro languageKnowledge/ experience working on CluepointsAbility to work in an autonomous way and engage with relevant stakeholders to execute activities related to study level centralized monitoring process.Ability to understand basic statistical analysis concepts and to interpret their outcome.Ability to maintain confidentiality of data and information during interactions with staff at all levelsAbility to work with limited close supervision.Demonstrated communication, interpersonal, organizational and problem-solving skillsHigh levels of initiative, drive and commitment.Prior experience in a Data Management related field is requiredExperience with relational databases, preferably Clinical Data Management and EDC SystemsExperience communicating with all levels of personnel and participating in collaborative work team (locally and globally). xcskxlj Advanced knowledge of federal regulations, Good Clinical Practice, and Good Clinical Data Management Practices.Excellent command, both verbal and written, of EnglishThis role is not eligible for UK visa sponsorshipEEO Minorities/Females/Protected Veterans/Disabled
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