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Responsibilities:
- Deliver site activation readiness on time and within quality standards, identifying and mitigating risks.
- Prepare and submit Clinical Trial Application forms and dossiers to Competent Authorities and Ethics Committees.
- Maintain project plans, trackers, and regulatory intelligence tools to support study start-up.
Qualifications:
- Bachelor’s degree in life sciences or related field, or Registered Nurse, with 3.5+ years in regulatory or site start-up.
- Excellent communication and organizational skills, with fluency in English and local language.
Competencies:
- Knowledge of ICH-GCP and local clinical trial regulations.
- Ability to work independently in a fast-paced environment and mentor junior specialists.
Precision Medicine Group
Precision Medicine Group provides clinical trial services, including regulatory and site start-up support. The company is expanding across Latin America and values expertise, collaboration, and compliance.