Senior Clinical Trial Manager – LATAM

🔥 14 hours ago

🌐 Brazil, Colombia, +1 more countries – Remote

🇧🇷 Brazil – Remote 🇨🇴 Colombia – Remote 🇲🇽 Mexico – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Serve as the primary clinical point of contact with the client • Own planning, execution, and oversight of clinical studies in compliance with protocol, SOPs, ICH-GCP, and regulatory requirements • Collaborate with the Project Manager on monthly invoicing and clinical budget variance management • Develop clinical study documents, plans, informed consent templates, study forms and manuals, CRF completion guidelines, trackers, presentation slides, and training materials • Identify and deliver study-specific training for CRAs and third-party vendors • Generate potential site lists and lead site feasibility • Identify enrollment risks and develop country recruitment and retention strategies • Manage feasibility, site start-up, enrollment, maintenance, and close-out procedures • Lead internal clinical team meetings and set expectations for CRAs and CTAs • Address CRA and site questions and maintain FAQ logs • Support investigator meetings and review or approve investigational product release packages • Oversee submissions and approvals to Competent Authorities and IRB/Ethics Committees • Develop clinical monitoring strategies and track study timelines and quality deliverables • Generate and use metrics reporting, including CTMS, DM query trends, and outstanding monitoring reports • Implement and manage the electronic Trial Master File (eTMF) • Collaborate with PM, CRAs, and QA on CAPA plans and ensure timely closure • Assist sites, internal staff, and CRAs with GCP audit preparation • Work with the PM on project-specific resourcing issues and escalate CRA performance or site compliance issues • Collaborate with data management and CRAs to ensure data quality and cleaning timelines • Manage investigational product processes, including drug accountability and reconciliation • Assume project management responsibilities when a cross-functional PM is not assigned • Support business development and marketing activities • Potentially negotiate site budgets and investigator contracts • Potentially review site visit reports and monitoring-plan execution • Potentially manage clinical vendors • Potentially perform clinical data review and query generation • Potentially have line management responsibilities • Perform other duties assigned by management

🎯 Requirements

• Bachelor’s degree or equivalent combination of education/experience in science or health-related field • 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) • Ability to travel domestically and internationally, including overnight stays • Mastery knowledge of ICH-GCP, relevant Precision SOPs, and regulatory guidance, with ability to implement • Working knowledge of clinical management techniques and tools • Direct work experience in a cross-functional environment • Proven experience in functional management and delegation while fostering cohesive team dynamics • Proven experience in planning, risk management, and change management • In-depth proven experience in pharmaceutical and/or device research required • Demonstrated successful independent negotiation and conflict management strategies • Advanced degree preferred

🏖️ Benefits

• Career growth opportunities, including opportunities to build teams, define processes, influence culture, and assume broader leadership and project management responsibilities • Regular full-time employment