Clinical trial submissions to regulatory authorities
Oversight of cros, vendors, and consultants
The Study Start-Up Head, LATAM is responsible for the identification, selection, activation, and maintenance of clinical sites of large, global, complex oncology clinical trials
Job Summary
The Study Start-Up Head, LATAM is responsible for the identification, selection, activation, and maintenance of clinical sites of large, global, complex oncology clinical trials.
Ensures start-up and maintenance clinical trial activities are executed to expected and specified timelines and quality standards, gathers and monitors start-up metrics to measure against KPIs.
Provides study-specific mentoring and line management for junior team members, as appropriate, and assumes leadership role in operational improvement initiatives.
Matching Summary
The Study Start-Up Head, LATAM is responsible for the identification, selection, activation, and maintenance of clinical sites of large, global, complex oncology clinical trials.
Skills & Requirements
Must-have
Study start-up and regulatory in Latin America
Clinical trial submissions to regulatory authorities
Oversight of CROs, vendors, and consultants
GCP, ICH guidelines, and SOPs
Fluent English required
Nice-to-have
Collaborative negotiation skills
Scientific or healthcare discipline
Hematology or Oncology therapeutic knowledge
Cross-functional mentoring and leadership
Key Requirements
8+ years' experience in clinical research
6+ years' experience in Study-Start-up and regulatory in Latin America
Bachelor’s degree or higher in a scientific or healthcare discipline
Masters degree in a scientific or healthcare discipline (preferred)
4+ years' experience in Study-Start-up and regulatory in Latin America (preferred with Masters)