Job Description
CDMX
What You Will Do
Trial Documentation & eTMF Management
Oversee clinical trial documentation, including CTA packages for Health Authority (HA) and Ethics Committee (EC) submissions.
Maintain and ensure compliance of the electronic Trial Master File (eTMF), including timely uploads, quality checks, and archiving at study closeout.
Support investigator TMF setup and documentation completeness.
Quality Oversight & Compliance
Perform compliance checks and process reviews across clinical study activities (e.g., regulatory, feasibility, study start-up, contracts, and trial management).
Ensure adherence to SOPs, local procedures, and regulatory requirements.
Document findings and track follow-up actions to closure.
SOP Deviations Management
Review and follow up on SOP deviations to ensure accuracy, completeness, and timely resolution.
Act as system owner for cross-study or multi-site deviations.
Coordinate stakeholders, track actions,...