Clinical Study Process Lead - Delivery & Compliance

IQVIA; Estado de México; On-site; MXN 700,000 - 1,050,000; Full time

Job summary

IQVIA is seeking a Study Process Lead to oversee and optimize clinical process execution for research projects. You will collaborate with CPCs/CPAs and management to ensure timely task planning, accurate documentation, and compliant eTMF/CTMS updates in line with global and local regulations.

Ideal candidates will have 3–4 years in clinical trial processes, strong English, and experience with CTMS/eTMF (Veeva Vault) and EDC systems.

Qualifications

• Proven experience in clinical trials operations and process ownership.
• Strong command of English and dense documentation practices.
• Experience with CTMS/eTMF systems (Veeva Vault preferred).
• Knowledge of EDC systems (Medidata) and regulatory/contract management tools.

Responsibilities

• Own assigned processes from design through execution and improvement.
• Lead task planning, resourcing, and delivery to meet deadlines.
• Provide ongoing training materials and SME guidance to CPCs/CPAs.
• Escalate performance issues promptly to leadership.
• Ensure eTMF/CTMS documentation quality and compliance.

Skills

English language

Microsoft Office

Project Management

CTMS/eTMF systems

EDC (Medidata)

Regulatory management systems

Contract management systems

Client facing

SME/Trainer

Tools

Veeva Vault eTMF

Job description

IQVIA is seeking a Study Process Lead to oversee and optimize clinical process execution for research projects. You will collaborate with CPCs/CPAs and management to ensure timely task planning, accurate documentation, and compliant eTMF/CTMS updates in line with global and local regulations.

Ideal candidates will have 3–4 years in clinical trial processes, strong English, and experience with CTMS/eTMF (Veeva Vault) and EDC systems.