Clinical Data Manager

31 lug - Siena
Altro

Direct message the job poster from Philogen S.p.A.
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
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 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 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
Benefits
A contract and salary proportional to the experience (seniority) of the successful candidate.
Location & EEO Statement
We 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.
Seniority level: Associate
Employment type: Full?time
Job function: Research
Industry: Pharmaceutical Manufacturing
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