4 дня назад
Clinical Trial Manager (LATAM)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Trial Manager (Clinical Operations): Leading and managing clinical studies across Latin America with an accent on regulatory compliance, site start-up, and recruitment strategies. Focus on overseeing the full study lifecycle, mentoring CRAs, and ensuring adherence to ICH-GCP standards.
Location: Remote, Mexico
Company
is a specialized organization focused on the planning, execution, and oversight of clinical trials.
What you will do
- Lead the planning, execution, and oversight of clinical studies across Mexico, Brazil, Argentina, Colombia, Chile, and Peru.
- Serve as the primary point of contact for clients and collaborate on budget and variance management.
- Develop essential clinical documents including clinical plans, Informed Consent Form templates, and training materials.
- Drive site feasibility, recruitment strategies, and site start-up processes.
- Mentor and lead a team of CRAs and CTAs, ensuring high-quality monitoring and data compliance.
- Manage eTMF implementation and coordinate with QA for CAPA implementation and GCP audit preparation.
Requirements
- Bachelor's degree in a science or health-related field; advanced degree preferred.
- Minimum of 7 years of clinical research experience, including significant clinical monitoring.
- Mastery of ICH-GCP, regulatory guidance, and clinical management tools.
- Must be based in Mexico.
- Ability to travel domestically and internationally.
- Proficiency in Microsoft Office Products (Outlook, Word, Excel, PowerPoint).
Nice to have
- Advanced degree in a relevant field.
Culture & Benefits
- High-impact opportunity to build and lead an expanding regional team.
- Significant career growth potential into broader leadership and project management roles.
- Remote work flexibility within Mexico.
- Dynamic, cross-functional environment with a focus on professional excellence and ethics.
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