Clinical Research Manager

This is a fully remote position, open to applicants in Argentina.

📋 Description

• Manage daily clinical operations to ensure adherence to protocols, SOPs, ICH/GCP, and regulatory standards.

• Act as the main operational liaison for Sponsors, providing updates, managing expectations, and guaranteeing high-quality execution of studies.

• Lead and mentor CRAs, including training, supervision, performance monitoring, co-monitoring, and reviewing/approving monitoring visit reports.

• Ensure optimal site and country performance through proactive assessment of monitoring activities, protocol deviations, data listings, recruitment progress, and escalation of issues.

• Oversee the quality of study documentation, including TMF quality, CTMS accuracy, monitoring plans, training plans, and study-specific materials.

• Collaborate with the Project Manager on study planning, investigator payments, resource allocation, study communications, and revenue forecasting.

• Participate in study meetings, Investigator Meetings, feasibility assessments, and, when necessary, local project management, CRA support, and bid defense initiatives.

⛳️ Requirements

• At least 5 years of clinical monitoring experience within a CRO, pharmaceutical, or biotechnology setting.

• A minimum of 1 year of experience in the role of Clinical Research Manager (CRM).

• Over 1 year of experience in Ophthalmology (OPH), preferably in retina indications such as DME, AMD, GA, RVO, or inherited retinal diseases (IRDs).

• Proficiency in English, Spanish, and Portuguese is essential.

• Strong comprehension of ICH/GCP, regulatory standards, and clinical operations processes.

• Proven capability to lead CRAs, manage study deliverables, and work collaboratively with cross-functional teams.

🏝️ Benefits

• Competitive compensation package.

• Comprehensive benefits.

• Opportunities for personal and professional growth.