Clinical Trial Manager (LATAM)
Remote
Job Summary
Lead planning, execution, and oversight of clinical studies across Mexico, Brazil, Argentina, Colombia, Chile, and Peru as the primary client contact. Drive site feasibility, recruitment strategies, and start-up processes while developing clinical documents, training materials, and monitoring strategies. Manage the internal clinical team, oversee regulatory submissions, and ensure compliance with ICH-GCP and protocol requirements. Collaborate with project management on budget variance, invoicing, and resource allocation. Review site visit reports, manage investigational product accountability, and lead corrective and preventative action plans. Support business development activities and negotiate site contracts as needed.
Required Qualifications
- Bachelor's degree or equivalent combination of education/experience in science or health-related field
- Advanced degree preferred
- Minimum of 7 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience
- Professional working proficiency in English required
- Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
- Excellent communication and interpersonal skills to effectively interface with others in a team setting
- Excellent organizational skills, attention to detail, and a customer service demeanor
- Ability to travel domestically and internationally including overnight stays
- Demonstrates mastery knowledge of ICH-GCP, relevant Precision SOPs, and regulatory guidance, as well as the ability to implement
- Working knowledge of clinical management techniques and tools
- Direct work experience in a cross-functional environment
- Proven experience in functional management including proven experience in delegating while fostering cohesive team dynamics
- Proven experience in planning, risk management and change management
- High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective
- Ability to lead and inspire excellence within a team
- Ability to create an environment where employees have a sense of ownership that will lead to increases in productivity and efficiency
- Results oriented, accountable, motivated and flexible
- Excellent time management, negotiation, critical thinking, decision making, analytical and interpersonal skills
- Excellent presentation, verbal and written communications skills
- In depth proven experience in pharmaceutical and/or device research required
- Demonstrated successful independent negotiation and conflict management strategies
Desired Qualifications
- Advanced degree
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