Hybrid Site Activation Manager - Regulatory Start-Up

Syneos Health Clinical; Ciudad de México; Hybrid; MXN 1,695,000 - 2,448,000; Full time

Job summary

Syneos Health Clinical is seeking a Site Activation Manager (FSP) with at least 2 years of local regulatory experience in Mexico. The role requires coordinating with Business Development, Contracts, PM, Clinical, and Data Management to drive site start-up timelines and regulatory submissions.

You will manage life cycle activities, amendments, and budget oversight while maintaining high-quality deliverables and strong stakeholder communication. Hybrid work arrangement available.

Qualifications

• Bachelor’s degree in a related field.
• Minimum 2 years of local regulatory experience in Mexico.
• Intermediate English.
• Ability to work in a hybrid environment.

Responsibilities

• Collaborates with major functional areas including Business Development, Alliance Management, Contracts and Proposals Development, SSU Country Managers, Project Management, Clinical, Data Management and Medical Writing.
• Identifies and evaluates issues pertaining to Site Start-Up, regulatory pathway, patient enrollment, and data interpretation to drive decisions.
• Ensures all project deliverables meet internal and customer expectations, providing projections, reports and updates with risk mitigation.
• Develops and maintains relationships with customers aligned to assigned projects and ensures targets and client needs are met.
• Oversees all SSU start-up deliverables and life cycle maintenance, including regulatory submissions and amendments.
• Prepares core submission documents and conducts regulatory impact assessments for amendments.
• Supports SIS/ICF development with PM and Medical Department and ensures TMF documentation compliance.

Skills

Regulatory experience

Site activation

Project management

Communication skills

Vendor management

Education

Bachelor's Degree

Higher Degree Preferred

Job description

Syneos Health Clinical is seeking a Site Activation Manager (FSP) with at least 2 years of local regulatory experience in Mexico. The role requires coordinating with Business Development, Contracts, PM, Clinical, and Data Management to drive site start-up timelines and regulatory submissions.

You will manage life cycle activities, amendments, and budget oversight while maintaining high-quality deliverables and strong stakeholder communication. Hybrid work arrangement available.