Site Partner II (Study Start Up - Regulatory Submissions)
HybridMexico City, Mexico City, Mexico
Job Summary
Lead the preparation, compilation, and quality review of submission packages for Ethics Committee (EC/IRB) and Ministry of Health reviews, ensuring documentation is complete, accurate, and submitted within established timelines. Develop and execute regulatory strategies for local authorities such as COFEPRIS to support efficient approval pathways and study activation. Coordinate with internal stakeholders, sponsors, and investigator sites to address queries and deficiencies arising from regulatory reviews. Provide regulatory guidance on local requirements, ICH-GCP guidelines, and sponsor expectations while monitoring changes in regulations to implement mitigation strategies minimizing activation delays. Maintain inspection-ready regulatory documentation within the Trial Master File and contribute to process improvements enhancing study start-up efficiency.
Required Qualifications
- Bachelor's degree in life sciences, healthcare, business, or a related field, or equivalent clinical research experience
- Experience in site-facing roles, site management, or clinical operations within CRO, pharma, or healthcare
- Strong communication, relationship-building, and problem-solving skills
- Good understanding of site operations and factors influencing recruitment and quality
- Organised and proactive, with the ability to manage multiple sites and competing priorities
- Collaborative team player with a commitment to delivering a high-quality site experience
- Legal right to work in the country where the role is based
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