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3 settimane fa

Siena, Italia Philogen A tempo pieno

Overview Philogen 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 qualified Clinical Data Manager who will report to the Data Manager Coordinator. Responsibilities Perform data cleaning activities on assigned studies Design paper and/or electronic Case Report Forms (CRFs) in collaboration with the clinical team Collaborate in the implementation and validation of clinical databases Prepare, maintain and archive data management documentation (e.g. Data Management Plan) Review all the clinical data listings and tables Ensure data management in accordance with applicable standards (e.g. CDISC), regulatory guidelines and company SOPs Participate in study team meetings Support the Pharmacovigilance department in SAEs reconciliation Review clinical study protocols and Clinical Study Reports Perform coding activities using medical dictionaries Qualifications Master’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 team Knowledge 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 skills Knowledge of medical terminology with expertise in oncology preferred; Knowledge of coding dictionaries (e.g. MedDRA); SAS Knowledge We offer A contract and salary proportional to the experience (seniority) of the successful candidate. Job location We invite interested candidates to submit their applications expressly authorizing the processing of personal data in accordance with Legislative Decree 196/2003. Our recruitment adheres to the provisions of Legislative Decree 198/2006, and we welcome applications from candidates of any gender orientation or expression, sexual orientation, age, ethnicity, or religious belief. #J-18808-Ljbffr

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