PSI CRO
PSI is a leading Contract Research Organization with 30 years experience in the industry, offering a perfect balance between stability and innovation to both clients and employees.
Requirements
- Serve as medical point of contact for internal project team, study sites and study sponsor for medical matters related to the conduct of clinical trials per protocol and per GCP guidelines
- Advise clients, project teams, sites, regulatory agencies and third-party vendors on medical matters
- Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, patient narratives, and scientific presentations
- Review and analysis of clinical data to ensure the safety of study participants in clinical trials
- Ensure that the reported trial data is accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendments
- Address safety issues across the trial from sites and the study team
- Provide support for medical data review
- Participate in bid defense meetings and proposal activities
- Assist in Pharmacovigilance activities
- Identify trial risks, and create and implement mitigation strategies with other relevant departments
- Organize and lead clinical development advisory boards and safety monitoring boards
- Ensure Study team compliance with FDA, EMEA, ICH and GCP guidelines
Benefits
- Full-time permanent employment in Estonia
Originally posted on Himalayas
To apply for this job please visit himalayas.app.
Working in Estonia
Estonia, officially the Republic of Estonia, is a country in the Baltic region of Northern Europe. It is bordered to the north by the Gulf of Finland across from Finland, to the west by the Baltic Sea across from Sweden, to the south by Latvia, and to the east by Russia. The territory of Estonia consists of the mainland, the larger islands of Saaremaa and Hiiumaa, and over 2,300 other islands and islets on the east coast of the Baltic Sea. Its capital city of Tallinn, along with the city of Tartu, are the country's two largest urban areas. The Estonian language, of the Finnic family, is the of
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