Clinical Research Manager

We are seeking a Clinical Research Manager to oversee local operational clinical trial activities in Chile. The successful candidate will be responsible for ensuring compliance with ICH GCP and country regulations, as well as building business relationships with investigators and external partners.

Job Summary: The Clinical Research Manager will play a critical role in managing clinical trials, ensuring compliance, and leading cross-functional teams. The ideal candidate will have a strong understanding of clinical trial planning, management, and metrics, as well as excellent communication and leadership skills.

Key Responsibilities:

• Performance: Ensure compliance with ICH/GCP and country regulations for assigned protocols (30%)
• Management: Drive execution and performance of deliverables for assigned protocols (20%)
• Quality Oversight: Oversee CRAs and CTCs on assigned projects and perform quality control visits (20%)
• External Customer Facing: Collaborate with functional outsourcing vendors, investigators, and external partners (20%)
• Internal Collaboration and Strategy: Align with internal stakeholders to support local and regional strategy development (10%)

Requirements:

• University/college degree in life sciences or related field
• Minimum 6-8 years of clinical research experience
• Thorough knowledge of ICH Guidelines and GCP
• Excellent communication and leadership skills
• Ability to work independently and in a team environment

Preferred Qualifications:

• Life science degree or certification in a related allied health profession
• Experience in pharmaceutical or CRO industries
• Working knowledge of ICH, FDA, local regulatory requirements, and IRB/IEC

Physical Demands/Work Environment:

• Client office as per assignment
• ≤ 20-40% travel may be required