Requirements: English
Company: Philogen S.p.A.
Region: Siena , Tuscany
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 rheumathologic 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.
In particular, the successful candidate will be responsible for:
- 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
The ideal candidate should have:
- 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;
- 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 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.
Job location:
Milano/Siena - Italy