Site Activation & Regulatory Start-Up Specialist

IQVIA; Ciudad de México; On-site; MXN 450,000 - 650,000; Full time

Job summary

IQVIA in Mexico City is seeking a Regulatory & Start Up Specialist 1 to manage country-level site activation activities, ensuring compliance with local and international regulations and SOPs.

You will serve as SPOC for investigative sites, activate sites, prepare regulatory documents, and maintain project systems while supporting timing and quality across the study.

This role requires strong English, analytical thinking, and the ability to handle multiple priorities in a fast-paced environment.

Qualifications

• Bachelor degree in life sciences completed.
• +1 year of clinical research experience and start-up management.
• Fluent English (written and spoken).
• Analytical and critical thinking; able to evaluate complex issues.
• Strong interpersonal skills with adaptability to changing requirements.
• Proven ability to manage multiple priorities in a fast-paced environment.

Responsibilities

• Act as SPOC for investigative sites, SAM, PM team and others; ensure SOP compliance.
• Perform start-up and site activation activities per regulations and SOPs.
• Prepare site regulatory documents for completeness and accuracy.
• Maintain internal systems and tracking tools with project data.
• Review site performance metrics and provide management feedback.
• Coordinate project planning, timelines and contingency plans.
• Inform team of regulatory and contract document completion.
• Monitor and follow up on document approvals and IP release timing.
• Provide local expertise to SAMs during planning.
• Quality control documents provided by sites.
• May contact sponsors on specific initiatives.

Skills

Fluent English

Analytical thinking

Interpersonal skills

Multiple priorities management

Clinical research experience

Study start-up management

Education

Bachelor's degree in life sciences

Job description

IQVIA in Mexico City is seeking a Regulatory & Start Up Specialist 1 to manage country-level site activation activities, ensuring compliance with local and international regulations and SOPs.

You will serve as SPOC for investigative sites, activate sites, prepare regulatory documents, and maintain project systems while supporting timing and quality across the study.

This role requires strong English, analytical thinking, and the ability to handle multiple priorities in a fast-paced environment.