Precision For Medicine is a healthcare and life sciences services organization that helps pharmaceutical and biotechnology companies develop and commercialize therapies, with expertise spanning oncology, rare diseases, and autoimmune conditions. Its work combines clinical trial management, laboratory services, biospecimen collection, biomarker capabilities, and manufacturing support to coordinate complex development programs. By connecting these services across the clinical research process, Precision For Medicine helps teams address operational challenges and advance potential treatments toward patients.
Senior Clinical Trial Manager, Latin America
Lead clinical study planning, monitoring, and delivery across Latin America for Precision for Medicine. Oversee sites, CRAs, regulatory submissions, recruitment, and study quality.
Description
- Act as the lead clinical contact for clients.
- Plan, execute, and oversee clinical studies in line with protocols, SOPs, ICH-GCP, and regulatory requirements.
- Partner with the Project Manager on monthly invoicing and clinical budget variances.
- Create study plans and materials, including consent templates, forms, manuals, CRF guidance, trackers, presentations, and training resources.
- Develop and deliver study-specific training for CRAs and third-party vendors.
- Build prospective site lists and lead site feasibility assessments.
- Spot enrollment risks and develop country-level recruitment and retention strategies.
- Manage study feasibility, site start-up, enrollment, maintenance, and close-out.
- Lead internal clinical team meetings and establish expectations for CRAs and CTAs.
- Respond to CRA and site questions and maintain FAQ records.
- Support investigator meetings and review or approve investigational product release packages.
- Oversee submissions and approvals with Competent Authorities and IRB or Ethics Committees.
- Set clinical monitoring strategies and track study schedules and quality deliverables.
- Produce and use metrics reports covering CTMS, data management query trends, and overdue monitoring reports.
- Implement and oversee the electronic Trial Master File (eTMF).
- Work with the Project Manager, CRAs, and QA on CAPA plans and drive their timely completion.
- Help sites, internal teams, and CRAs prepare for GCP audits.
- Coordinate project resourcing with the Project Manager and escalate CRA performance or site compliance concerns.
- Partner with data management and CRAs to maintain data quality and meet data cleaning timelines.
- Oversee investigational product handling, accountability, and reconciliation.
- Take on project management duties when no cross-functional Project Manager is assigned.
- Contribute to business development and marketing activities.
- May negotiate site budgets and investigator contracts.
- May review site visit reports and monitoring plan implementation.
- May oversee clinical vendors.
- May conduct clinical data reviews and generate queries.
- May have line management duties.
- Carry out other duties assigned by management.
Requirements
- Bachelor’s degree or an equivalent combination of education and experience in a science or health-related field.
- At least 7 years of clinical research experience, or demonstrated competencies for the role, including substantial clinical monitoring experience.
- Professional working proficiency in English.
- Experience using Microsoft Office applications, including Outlook, Word, Excel, and PowerPoint.
- Ability to travel domestically and internationally, including overnight trips.
- Strong command of ICH-GCP, relevant Precision SOPs, and regulatory guidance, with the ability to apply them.
- Working knowledge of clinical management methods and tools.
- Direct experience working in a cross-functional environment.
- Demonstrated functional management and delegation skills, with the ability to build cohesive teams.
- Demonstrated experience in planning, risk management, and change management.
- Substantial experience in pharmaceutical and/or medical device research.
- Demonstrated ability to negotiate independently and manage conflict effectively.
- An advanced degree is preferred.
Benefits
- Opportunities for career advancement, team building, process development, cultural influence, and expanded leadership and project management responsibilities.
- Regular full-time employment.