Study Startup Lead

hace 1 semana


Ciudad de México, Ciudad de México PSI A tiempo completo

Job Description

Take your career to the next level and be involved in study startup processes in Mexico. You will provide direct operational support to project teams and ensure that PSI clinical projects start smoothly and on time.

Home-based

You will:

Oversee and coordinate the processes critical for clinical trial sites activation Communicate with project teams, investigative sites, review bodies, vendors, and clients regarding startup matters till the moment of site activation Support site identification and selection process Collect, review, and submit documents for ethics and regulatory review and approval Prepare packages of site documents for drug release to clinical sites Develop and negotiate site contracts and budgets Monitor startup metrics and timelines Coordinate initiatives for startup process improvement, analyze best practices and challenges

Qualifications

College/University degree or an equivalent combination of education, training and experience Minimum 3 years of industry experience in clinical research with practical startup experience in the Country/ Region Excellent knowledge of ICH GCP, local laws and applicable regulations in the region Full working proficiency in English and Spanish Communication and organizational skills Ability to negotiate and build relationships at all levels Experience in mentoring and leadership is preferred
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