Clinical Development Physician
hace 1 semana
Company Overview:
PSI CRO is a leading Contract Research Organization with over two and a half decades of experience in the industry, providing a perfect balance between stability and innovation for both clients and employees. We focus on delivering high-quality services on time across various therapeutic areas.
Job Description:
A Medical Science Consultant at PSI CRO will provide medical input to global clinical studies and advise teams and business partners while prioritizing patients' safety and well-being. The role is home-based in Mexico.
Responsibilities:
- Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies, and third-party vendors on medical matters.
- Collaborate with internal departments in preparing clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and scientific presentations.
- Review and analyze clinical data to ensure the safety of study participants in clinical studies.
- Ensure reported data accuracy, completeness, and verifiability, as well as compliance with approved protocols/amendments.
- Address safety issues across the study from sites and the study team.
- Review listings for coded events to verify Medical Dictionary for Regulatory Activities.
- Assist in Pharmacovigilance activities.
- Identify program risks and create mitigation strategies with Clinical Operations.
- Ability to organize and lead clinical development advisory boards and safety monitoring boards.
- Ensure Study team compliance with FDA, EMEA, ICH, and GCP guidelines.
- Review and sign off clinical documents regarding medical relevance.
Qualifications:
- Internal Medicine certification is mandatory.
- Prior and extensive experience in medical practice/patient care (minimum 10 years).
- Prior experience working with clinical trials is advantageous.
- Prior experience with ICU is advantageous.
- Full proficiency in English and Spanish.
- Proficiency with MS Office applications.
- Excellent communication, presentation, and analytical skills.
- Strong problem-solving, teamwork, and attention to detail.
Estimated Salary: $120,000 - $180,000 per annum based on location and experience.
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