clinical data manager

1 settimana fa

Siena, Toscana, Italia Philogen S.p.A. A tempo pieno 40.000 € - 60.000 € all'ano

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

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