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