Clinical Study Administrator
On-siteMexico City, Mexico City, Mexico
Job Summary
Coordinate clinical study activities from start-up through execution and close-out, ensuring quality and consistency of interventional study deliverables. Collect, prepare, and track documents for application processes, including timely submissions to EC/IRB and regulatory authorities. Maintain the local eTMF and ISF for inspection readiness while managing study materials, equipment, and contract preparation at the site level. Prepare and distribute presentation material for meetings, newsletters, and websites, supporting local translation and document distribution. Liaise with investigators, external service providers, and CRAs to facilitate document delivery and study team coordination.
Required Qualifications
- Scientific degree
- Previous administrative experience preferably in the medical/ life science field
- Proven organizational and administrative skills
- Computer proficiency (Veeva Clinical Vault, SAP S/4HANA, Coupa)
- Good knowledge of spoken and written English
Desired Qualifications
- Working knowledge of the Clinical Study Process
- Understanding of the range of working procedures relating to it
- Understanding of the ICH-GCP guidelines
- Ability to develop advanced computer skills to increase efficiency in daily tasks
- Good verbal and written communication
- Good interpersonal skills and ability to work in an international team environment
- Willingness and ability to train others on study administration procedures
- Excellent organization and time management skills
- Excellent attention to detail
- Ability to multi-task in a high-volume environment with shifting priorities
- Team oriented and flexible
- Ability to respond quickly to shifting demands and opportunities
- Integrity and high ethical standards
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