Clinical Data Management Specialist

Everest Clinical Research is a full-service contract research organization providing clinical research services to pharmaceutical, biotechnology, and medical device industries. They are seeking a Clinical Data Management Specialist to perform data entry and processing activities, assist in data management tasks, and ensure compliance with trial Sponsors' requirements.ResponsibilitiesPerform data entry and processing activities for assigned projectsAssist the primary Data Manager in performing data management activitiesWrite Data Management Plans (DMP; including specifying database integrity checks)Design clinical trial Case Report Forms (CRFs)Design databases, monitor data flow, and quality control processesWrite draft DMPs using standard DMP templateAssist in defining and monitoring clinical trial data flow and quality control processes in accordance with corporate standard operating procedures (SOPs), Good Working Practices, and divisional guidelinesAssist in designing and reviewing patient CRFs and database schemaTest data capture/entry screens and edit specificationsAssist in designing databases following database design standards and conventions that have been established by the company or the trial SponsorAccurately and efficiently validate electronically captured dataWrite clear queries on missing data and data points failing pre-defined range checks and/or logical checksAssist in performing data quality control procedures during the trial and additional database closure checks at the end of the studyValidate and distribute study monitoring reports to internal and external study team membersAssist in resolving data coding discrepancies resulting from the coding of medical events, procedures, and medicationsMaintain and prepare for final archival of data management documentation relevant to the assigned clinical trialsAssist the corporate archivist in assembling and archiving such documentationAssist data management quality assurance (QA) personnel in performing QA procedures on trial CRFs, database schema and databases for assigned studiesPerform line-by-line checks on subject data listings against completed CRFsCompare database schema against annotated CRFsCompare final paper CRFs against CRF images that were captured during the trialSkillsA Bachelors' or Masters' degree in health and/or pharmaceutical sciences, physical/biological, or chemistry fieldsEducation or experience must demonstrate the ability to work independently and to apply data management concepts, clinical trial data capture and management techniques, and logical and algebraic operationsCompany OverviewEverest Clinical Research is a firm which conducts clinical research by contract for firms across the globe in fields It was founded in 2004, and is headquartered in Markham, Ontario, CAN, with a workforce of 501-1000 employees. Its website is https://www.ecrscorp.com/.



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