Clinical Development Specialist

hace 19 horas


Xico, México Psi Cro Ag A tiempo completo
Job Overview

We are seeking a skilled Clinical Development Specialist to join our team at Psi Cro Ag.

About the Role

This is a home-based position in Mexico, requiring collaboration with internal departments and external partners to deliver quality services across various therapeutic indications.

Key Responsibilities
  • Provide medical input to global clinical studies, advising teams and business partners on medical matters while ensuring patients' safety and well-being.
  • Collaborate with internal departments to prepare clinical development plans, protocols, investigator brochures, annual reports, and scientific presentations.
  • Analyze clinical data to ensure the safety of study participants and verify accuracy, completeness, and verifiability of reported data.
  • Address safety issues across the study from sites and the study team, reviewing listings for coded events and verifying Medical Dictionary for Regulatory Activities.
  • Participate in Pharmacovigilance activities, identifying program risks, and creating mitigation strategies with Clinical Operations.
  • Organize and lead clinical development advisory boards and safety monitoring boards, ensuring compliance with FDA, EMEA, ICH, and GCP guidelines.
Requirements
  • Internal Medicine certification is mandatory, along with prior experience in medical practice or patient care (minimum 10 years).
  • Prior experience working with clinical trials is an advantage, as is experience with ICU.
  • Proficiency in English and Spanish is required, along with MS Office applications and strong communication, presentation, and analytical skills.
Compensation and Benefits

The estimated salary for this position is $120,000 - $180,000 annually, depending on experience.

As a valued member of our team, you will enjoy a range of benefits, including a competitive salary, opportunities for career growth, and a dynamic work environment that supports your professional development.



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