Medical Science Specialist
hace 4 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:- Medical Input and Advice: Provide medical input to global clinical studies and advise teams and business partners on medical matters.
- Clinical Development Planning: Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and scientific presentations.
- Data Review and Analysis: Review and analyze clinical data to ensure the safety of study participants.
- Regulatory Compliance: Ensure that reported data is accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendments.
- Safety Issue Resolution: Address safety issues across the study from sites and the study team.
- Medical Dictionary Review: Review listings for coded events to verify Medical Dictionary for Regulatory activities.
- Pharmacovigilance Activities: Assist in Pharmacovigilance activities.
- Program Risk Management: Identify Program risks, and create and implement mitigation strategies with Clinical Operations.
- Advisory Board Participation: Participate in bid defense meetings and clinical development advisory boards.
- Medical Degree: Medical Doctor degree.
- Certification: Internal Medicine certification is a must.
- Experience: Prior and wide experience in medical practice/patient care (minimum of 10 years).
- Language Skills: Full working proficiency in English and Spanish.
- Software Skills: Proficiency with MS Office applications.
- Soft Skills: Communication, presentation, and analytical skills, problem-solving, team, and detail-oriented.
As a member of our Medical Monitoring team, you will join our international group of medical professionals, build a career on the frontline of medical science, and use your knowledge and expertise to help bring new medications to patients who need them.
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