CLINICAL DATA MANAGER

17 ago - Siena
Philogen

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)

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