Philogen S.p.A. would like to hire a CLINICAL DATA MANAGER to support our Clinical Department.
- 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
- Manage discrepancies
- Review clinical study protocols and Clinical Study Reports
- Perform coding activities using medical dictionaries
- Perform database lock process
- Minimum Bachelor’s degree (health, clinical, biological or pharmaceutical science – or a related field preferred) with 2-3 years equivalent level of experience in pharmaceutical/biotech, or CRO setting or Master’s degree without any equivalent level of experience in pharmaceutical/biotech, or CRO setting
- Extensive experience working with data management on data checking
- Knowledge of SAS system and data standards (CDISC) is considered a plus
- Knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
- Strong interpersonal, organizational, and multi-tasking skills
- Excellent attention to detail and problem-solving skills
- Windows applications: Word, Excel, Powerpoint, etc.
- A previous experience in a similar role is preferred
A contract and salary proportional to the experience of the successful candidate.
Siena – Italy