Clinical Research Operations Manager
hace 1 semana
Job Description
As a key member of the PSI team, you will play a critical role in the successful execution of clinical trials in Mexico. Your primary responsibility will be to provide direct operational support to project teams, ensuring that clinical projects start smoothly and on time from home-based location.
You will oversee and coordinate the processes critical for clinical trial sites activation, communicating with project teams, investigative sites, review bodies, vendors, and clients regarding startup matters until the moment of site activation. Your tasks will include:
- Supporting site identification and selection process
- Collecting, reviewing, and submitting documents for ethics and regulatory review and approval
- Preparing packages of site documents for drug release to clinical sites
- Developing and negotiating site contracts and budgets
- Monitoring startup metrics and timelines
- Coordinating initiatives for startup process improvement, analyzing best practices and challenges
Requirements
- 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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