Start Up Lead (LATAM)

TL;DR

Start Up Lead (LATAM): Execution of global site start-up strategy and planning for clinical trials, including document collection, ICF customization, IRB/EC and CA/MoH submissions, and delivery of IMP release packages. Focus on critical path planning, risk mitigations, stakeholder collaboration, and oversight of metrics for timely site activation.

Remote, Mexico (expanding across LATAM: Brazil, Argentina, Colombia, Chile, Peru)

Company

CRO focused on precision medicine, expanding clinical trial capabilities in LATAM.

What you will do

• Manage site start-up process through activation readiness strategy and oversight of delivery.
• Develop and present critical path planning including IRB/EC & CA/MoH strategy, ICF customization, risk mitigations, IMP release, and contract execution.
• Collaborate with stakeholders for milestone planning, operational alignment, and timely site activation.
• Participate in client meetings to set expectations on delivery, communication, risk mitigation, and metrics.
• Partner with functional leaders and specialists to identify risks, execute mitigations, and maintain tracking systems.
• Coordinate translations, maintain communication with key functions, and act as SME for country-specific start-up activities.
• Support training, mentoring, country summaries, and client proposals as needed.

Requirements

• Bachelor's in life sciences or related, or RN; 5+ years in start-up (ideally SU Lead/PM in CRO/pharma/biotech)
• 2+ years in project milestone management, resources, budgets, team coordination
• Fluency in English and local language of country (e.g., Spanish for Mexico)
• Demonstrated leadership in cross-functional activities
• Excellent communication, organizational skills; experience with milestone tracking tools/systems
• Knowledge of GCP/ICH guidelines and regulatory requirements

Nice to have

• Advanced degree in life sciences

Culture & Benefits

• #LI-REMOTE indicates remote work support
• Fast-paced environment with sense of urgency
• Occasional travel may be required
• Equal Opportunity Employer