Cra - Italy

1 giorno fa

Roma, 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 on-site monitoring visits (pre-study, 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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