Lead Clinical Study Process & Compliance

IQVIA; Ciudad de México; On-site; MXN 900,000 - 1,400,000; Full time

Job summary

IQVIA in Mexico City is seeking a Study Process Lead to oversee processes across eTMF, EDC review, CTMS updates, and payment reconciliations for clinical projects while ensuring regulatory compliance and client satisfaction.

You will mentor CPCs/CPAs, manage process documentation, and act as the main contact for task planning and process improvements, coordinating with LM and client stakeholders.

Qualifications

• 3–4 years of experience in the clinical trial industry (CRO preferred).
• Excellent command of English and Microsoft Office.
• 2+ years with CTMS/eTMF (preferably Veeva Vault).
• Experience with EDC, regulatory management, and contract management is a plus.

Responsibilities

• Own assigned processes from creation through execution and improvement.
• Oversee task progress, ensure deadlines, and escalate risks.
• Provide training and create guidance materials for task completion.
• Coordinate with Client, CPCs/CPAs and LM team on performance and issues.
• Support eTMF management, regulatory filing, and payments reconciliations.

Skills

English language

Project management

Advanced Excel features

Tools

CTMS (Veeva Vault) and eTMF (Veeva Vault)

EDC (Medidata)

Microsoft Office

Job description

IQVIA in Mexico City is seeking a Study Process Lead to oversee processes across eTMF, EDC review, CTMS updates, and payment reconciliations for clinical projects while ensuring regulatory compliance and client satisfaction.

You will mentor CPCs/CPAs, manage process documentation, and act as the main contact for task planning and process improvements, coordinating with LM and client stakeholders.