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Job Title: CLINICAL DATA MANAGER
Location: Siena - Italy
Department: Clinical
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 rheumatologic 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
* Perform database lock process
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 skills
* Ability to prioritize tasks and handle multiple projects at once and in 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.
Location
Milano/Siena - Italy
How to apply
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.
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