Medical Science Specialist
hace 5 días
At PSI CRO, we are seeking a highly skilled Medical Monitor to join our team of medical professionals. As a Medical Monitor, you will play a critical role in ensuring the safety and well-being of study participants in clinical studies.
Key Responsibilities:- Provide medical input to global clinical studies and advise teams and business partners on medical matters.
- Collaborate with internal departments to prepare clinical development plans, protocols, and reports.
- Review and analyze clinical data to ensure the safety of study participants.
- Ensure data accuracy, completeness, and verifiability, and that trial conduct is in compliance with approved protocols.
- Address safety issues across the study and review listings for coded events.
- Participate in bid defense meetings and assist in Pharmacovigilance activities.
- Identify program risks and create mitigation strategies with Clinical Operations.
- Organize and lead clinical development advisory boards and safety monitoring boards.
- Ensure study team compliance with FDA, EMEA, ICH, and GCP guidelines.
- Medical Doctor degree.
- Internal Medicine certification is a must.
- Prior experience in medical practice/patient care (minimum of 10 years).
- Prior experience working with clinical trials is a plus.
- Prior experience with ICU is a plus.
- Full working proficiency in English and Spanish.
- Proficiency with MS Office applications.
- Communication, presentation, and analytical skills.
- Problem-solving, team, and detail-oriented.
As a Medical Monitor at PSI CRO, you will join our international group of medical professionals and contribute to the development of new medications that improve patients' lives. We offer a dynamic and challenging work environment that fosters growth and collaboration.
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