Medical Monitor (Infectious Diseases)
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners while always focusing on patients safety and well-being.
Full-time employment based in Sofia Bulgaria
Responsibilities:
- 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 manuscripts and different scientific presentations
- Review and analysis of clinical data to ensure the safety of study participants in clinical studies
- Ensure that the reported 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 study from sites and the study team
- Provide support to medical data review
- Participate in bid defense meetings and proposal activities
- Assist in Pharmacovigilance activities
- Identify trial risks and create and implement mitigation strategies together with other relevant departments
- Ability to organize and lead clinical development advisory boards and safety monitoring boards
- Ensure Study team compliance with FDA EMEA ICH and GCP guidelines
Qualifications :
- Medical Doctor degree
- Infectious Diseases Fellowship certification is a must
- Prior and wide experience as a practicing MD (minimum of 10 years)
- Full working proficiency in English
- Proficiency with MS Office applications
- Communication presentation and analytical skills
- Problem-solving team and detail-oriented
Additional Information :
- Stable privately-owned company organically growing since 1995
- Comfortable office facilities with easy commute; opportunities to work office-based/hybrid
- Intensive induction program industry-related trainings for an optimal start and continuous development
- Friendly and supportive atmosphere in a committed team
- International environment with colleagues around the world
- Attractive income package; performance-based bonuses; corporate benefits
Remote Work :
No
Employment Type :
Full-time
Key Skills
About Company
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on on-time project delivery. This is achieved through investing substantial effo ... View more
