Internal Clinical Expert

Area
Medical Devices Business Sector
Job Function
Internal Clinical Expert
Activities
The Internal Clinical Expert acts as a team member supporting and executing the assessment of Clinical Evaluation and Safety Surveillance Report prepared by manufacturers of medical devices. Main tasks are:
  • Ability to assess clinical data prepared by medical device manufacturer in order to comply to medical device requirements;
  • Ability to assess the clinical innovation of a medical devices;
  • Ability to scientifically challenge clinical data assessed;
  • Ability to oversee and evaluate clinical specialist output and to manage, coach and support the activities carried out from the clinical specialist;
  • Ability to work both independently and in a team environment;
  • Ability to establish and maintain effective working relationships with co-workers, managers and clients;
  • Computer skills, including MS office, Word, PowerPoint, Excel, Outlook and Internet.
Profile
The ideal candidate will have a medical university degree and at least four years of practical working experience in Clinical Research, Clinical trials, Monitors and Pharmacovigilance activities as well as medical writing experience in the field of medical devices or medicinal substances. A very good knowledge of the principal standards and guidelines related to clinical aspects are required (ISO 14155 and GCP), as well as a sound of knowledge of medical device regulatory requirements in preclinical, clinical and post market clinical follow up. Proven ability to work in a distributed and multicultural team, proactivity and advanced knowledge of the Italian and English language are required. A sound knowledge of French or German language is preferential.