Site Activation & Regulatory Specialist

IQVIA; Estado de México; On-site; MXN 300,000 - 420,000; Full time

Job summary

IQVIA seeks a Regulatory & Start Up Specialist 1, cFSP to manage site activation tasks country-wide, ensuring regulatory compliance and timely deliverables. You will act as the SPOC for sites, SAMs, and project teams, coordinating start-up activities and regulatory documentation with attention to accuracy and process adherence.

You will also maintain project systems, monitor timelines, and provide expert local regulatory guidance to the team, aligning with SOPs and study requirements in a

Qualifications

• Bachelor's degree in life sciences completed.
• At least 1 year of clinical research experience and start-up management exposure.
• Fluent English, written and spoken.
• Strong analytical and critical thinking abilities.
• Good interpersonal and communication skills with adaptability.
• Evidence of successful execution in start-up contexts and multi-priority work.

Responsibilities

• Serve as Single Point of Contact (SPOC) for sites and project teams.
• Lead start-up and site activation activities in compliance with regulations.
• Prepare and review site regulatory documents for completeness.
• Maintain internal systems and tracking tools with project data.
• Provide feedback on site performance metrics to management.
• Plan project timelines and ensure regulatory milestones are met.
• Coordinate document approvals and IP release in line with timelines.
• Offer local regulatory expertise to SAMs and project teams.
• Perform quality control on site documents and communicate with sponsors as needed.

Skills

Clinical research experience

Start-up management

Analytical thinking

Interpersonal skills

Fluent English

Education

Bachelor's degree in life sciences

Job description

IQVIA seeks a Regulatory & Start Up Specialist 1, cFSP to manage site activation tasks country-wide, ensuring regulatory compliance and timely deliverables. You will act as the SPOC for sites, SAMs, and project teams, coordinating start-up activities and regulatory documentation with attention to accuracy and process adherence.

You will also maintain project systems, monitor timelines, and provide expert local regulatory guidance to the team, aligning with SOPs and study requirements in a