Cra - Italy

2 settimane fa


Roma, Lazio, Italia Linical Europe A tempo pieno
Linical Co., Ltd.

('Linical') is a premier global CRO headquartered in Osaka, Japan, listed in the prime segment of the Tokyo Stock exchange, and dedicated to serve its clients as a true partner in development.

With more than 700 employees Linical directly covers a total of more than 20 countries in Europe, North America and Asia-Pacific including Japan via its own offices and staff.

Linical's European arm is headquartered in Frankfurt, Germany with a substantial presence in Paris and Madrid. Its geographic footprint facilitates a significant presence in the leading Western European markets, combined with well-established affiliate operations in key emerging markets in Central
- and Eastern Europe.

Role summary:

- balance, performing a lower number of site visits.

You can work fully home
- based from any Italian city.

Responsibilities:

  • Ensure that the conduct of the study is in compliance with the currently approved study protocol/amendment(s), with ICH GCP, SOPs, and any applicable regulatory requirements in the assigned countries
  • Conduct any kind of onsite monitoring visits (prestudy, initiation, routine monitoring, site closure)
  • Review of and/or input to the study protocol, CRF and validation tools
  • Preparation and/or review of Monitoring Guidelines, CRF Completion Guideline, patient information documents
  • Preparation of submissions to Independent Ethics Committees (central and local) and to Competent Authorities
  • Assisting of Investigator and Institution contracts, negotiating budgets and arranging site payments
  • Query management in cooperation with the Clinical Data Management Team
  • Assisting sites and the study team in managing contacts to external service providers such as central laboratories
  • Participation in feasibility studies and Investigator selection
  • Responsibility for Site Management

Experience & Qualifications:

  • University degree in sciences or related fields, as well as experience & knowledge of clinical trials and regulations
  • Advanced English & fluent Italian
  • At least 1 year of experience within Clinical Monitoring in a pharmaceutical company or a CRO
  • Sound knowledge of relevant guidelines (e.g. ICH GCP) and regulatory requirements
  • Travel availability across Italy

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