Clinical Data Manager

1 settimana fa

Viù, Italia Philogen A tempo pieno

OverviewPhilogen S.p.A. is a biotechnology company whose mission is the development of biologic products for the imaging and therapy of life-threatening diseases, with a strategic focus on cancer diseases and rheumathologic disorders.Philogen S.p.A. would like to hire a highly motivated and qualifiedClinical Data Managerwho will report to the Data Manager Coordinator.ResponsibilitiesPerform data cleaning activities on assigned studiesDesign paper and/or electronic Case Report Forms (CRFs) in collaboration with the clinical teamCollaborate in the implementation and validation of clinical databasesPrepare, maintain and archive data management documentation (e.g. Data Management Plan)Review all the clinical data listings and tablesEnsure data management in accordance with applicable standards (e.g. CDISC), regulatory guidelines and company SOPsParticipate in study team meetingsSupport the Pharmacovigilance department in SAEs reconciliationReview clinical study protocols and Clinical Study ReportsPerform coding activities using medical dictionariesQualificationsMaster's degree in healthcare or a related field;2 years of experience with clinical trial research and data management;Meticulous attention to detail;Strong organizational;Ability to prioritize tasks and handle multiple projects at once and stressful situations;Ability to work in cross-functional study teamKnowledge of clinical research procedures and regulations;Good knowledge of MS Excel and Office packages in general;Good skills in data analysis;Ability to communicate effectively (both verbally and in writing);A clear understanding of the benefits of clinical trial research.Preferred skillsKnowledge of medical terminology with expertise in oncology preferred;Knowledge of coding dictionaries (e.g. MedDRA);SAS KnowledgeWe offerA contract and salary proportional to the experience (seniority) of the successful candidate.Job locationWe invite interested candidates to submit their applications expressly authorizing the processing of personal data in accordance with Legislative Decree ********.Our recruitment adheres to the provisions of Legislative Decree ********, and we welcome applications from candidates of any gender orientation or expression, sexual orientation, age, ethnicity, or religious belief.#J-*****-Ljbffr

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