Site Activation Partner
New
BrazilFull-TimeMiddle
Salary not disclosed
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Job Details
- Experience
- Minimum of 2 years
- Required Skills
- Project ManagementCompliance
Requirements
- Bachelor’s degree in Life Sciences or a related field
- Minimum of 2 years of experience in clinical research, regulatory affairs, or study start-up activities
- Strong understanding of clinical trial regulatory frameworks, including ICH-GCP and relevant local requirements
- Experience supporting clinical studies in the United States or other regulated international markets
- Excellent organizational and project management skills
- Strong communication and interpersonal skills
- High attention to detail and strong documentation and compliance mindset
Responsibilities
- Lead and support the preparation, submission, and tracking of regulatory documents required for clinical trial start-up, including ethics committee and regulatory authority submissions
- Coordinate with internal teams, study sites, and external stakeholders to ensure timely approvals and study activation readiness
- Maintain accurate and complete records of regulatory documentation, approvals, and correspondence throughout the study start-up lifecycle
- Provide guidance to study teams on regulatory requirements, best practices, and compliance standards for clinical trial initiation
- Support cross-functional collaboration to resolve issues and ensure smooth execution of site activation activities
- Contribute to process improvement initiatives aimed at increasing efficiency and standardization in study start-up workflows
- Ensure compliance with ICH-GCP guidelines and applicable local and international regulatory requirements
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