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 special focus on angiogenesis related disorders.
Philogen S.p.A. is looking for a Clinical Data Manager to support the development of the Clinical Department.
In particular the successful candidate will give support in the following activities:
- Review and contribute to the development of CRF's and related documents.
- Design eCRF in EDC systems according to study protocol (definition of variable, modules, visits and implementation of validation checks).
- Build, test and validate clinical database.
- Query data inconsistencies and revise case report forms in compliance with standard operating procedures.
- Review case report forms for completeness and consistency.
- Providing timely and professional ongoing quality management of clinical trial data by identifying errors/inconsistencies in CRF data and ensuring their resolutions.
- generating trial data listings and reports on the collected data.
- Develop and execute SOPs, departmental guidelines and data standards to guarantee database quality control and data management compliance.
The ideal candidate should have:
· Excellent written, verbal and organizational skills.
· Strong prioritization skills.
· Ability to handle multiple projects and stressful situations.
· Good computer skills.
· Good knowledge of MS Excel and Office package in general.
· Good skills in data analysis.
· Knowledge of medical terminology with expertise in oncology preferred.
· Knowledge of coding dictionaries (MedDRA, WHO drug).
· Knowledge of programming language
A contract and salary proportional to the experience (seniority) of the successful candidate.
Interested candidates are kindly asked to send their Curriculum Vitae to the following e-mail address firstname.lastname@example.org, specifying the job position of interest authorizing the process of personal data under Italian Legislative Decree 196/03 and General Data Protection EU Regulation (2016/679).