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Clinical data manager

Siena
Philogen S.p.A.
Pubblicato il 8 gennaio
Descrizione

PpDirect message the job poster from Philogen S.p.A. /p pPhilogen 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 rheumatologic disorders. /p pPhilogen S.p.A. would like to hire a highly motivated and qualified bClinical Data Manager /b who will report to the Data Manager Coordinator. /p h3Responsibilities /h3 ul liPerform data cleaning activities on assigned studies /li liDesign paper and/or electronic Case Report Forms (CRFs) in collaboration with the clinical team /li liCollaborate in the implementation and validation of clinical databases /li liPrepare, maintain and archive data management documentation (e.g. Data Management Plan) /li liReview all the clinical data listings and tables /li liEnsure data management in accordance with applicable standards (e.g. CDISC), regulatory guidelines and company SOPs /li liParticipate in study team meetings /li liSupport the Pharmacovigilance department in SAEs reconciliation /li liReview clinical study protocols and Clinical Study Reports /li liPerform coding activities using medical dictionaries /li /ul h3Qualifications /h3 ul liMaster's degree in healthcare or a related field /li li2 years of experience with clinical trial research and data management /li liMeticulous attention to detail /li liStrong organizational skills /li liAbility to prioritize tasks and handle multiple projects at once and stressful situations /li liAbility to work in cross‑functional study team /li liKnowledge of clinical research procedures and regulations /li liGood knowledge of MS Excel and Office packages in general /li liGood skills in data analysis /li liAbility to communicate effectively (both verbally and writing) /li liA clear understanding of the benefits of clinical trial research /li /ul h3Preferred skills /h3 ul liKnowledge of medical terminology with expertise in oncology preferred /li liKnowledge of coding dictionaries (e.g. MedDRA) /li liSAS Knowledge /li /ul h3Benefits /h3 ul liA contract and salary proportional to the experience (seniority) of the successful candidate. /li /ul h3Location EEO Statement /h3 pWe 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. /p pSeniority level: Associate /p pEmployment type: Full‑time /p pJob function: Research /p pIndustry: Pharmaceutical Manufacturing /p /p #J-18808-Ljbffr

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