Site Activation Lead - Regulatory (Mexico), Hybrid

7250 inVentiv Health Clinical Mexico, S.A. de C.V.; Ciudad de México; Hybrid; MXN 900,000 - 1,200,000; Full time

Job summary

Syneos Health is seeking a Site Activation Manager (FSP) in Mexico City. You will collaborate with cross-functional teams to manage start-up activities, regulatory submissions, and vendor coordination, ensuring on-time delivery and compliance with ICH-GCP.

The ideal candidate has at least 2 years of local regulatory experience in Mexico, strong project management skills, and excellent communication. This hybrid role combines on-site and remote work in CDMX.

Qualifications

• Bachelor’s Degree required; higher degree preferred.
• Strong knowledge of clinical trial processes (Ph II-IV) and ICH-GCP.
• Experience with startup activities and regulatory processes in Mexico.
• Excellent communication, negotiation and problem-solving skills.
• Ability to manage multiple projects and vendors in a fast-paced environment.

Responsibilities

• Collaborates with multiple functional areas to manage Site Start-Up and regulatory pathway.
• Ensure timely start-up deliverables, regulatory submissions, and vendor coordination.
• Prepare and present SSU strategy and status at client meetings; monitor budgets and profitability.
• Maintain country-specific applications and TMF documentation; ensure compliance with SOPs.

Skills

Clinical trials

Project management

Vendor management

Communication skills

Negotiation

Problem solving

Education

Bachelor’s Degree

Higher Degree Preferred

Job description

Syneos Health is seeking a Site Activation Manager (FSP) in Mexico City. You will collaborate with cross-functional teams to manage start-up activities, regulatory submissions, and vendor coordination, ensuring on-time delivery and compliance with ICH-GCP.

The ideal candidate has at least 2 years of local regulatory experience in Mexico, strong project management skills, and excellent communication. This hybrid role combines on-site and remote work in CDMX.