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 21%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 $35.2M Venture Round on 2021-03

Consulting • Healthcare • Logistics

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 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 documents, including clinical plans, informed consent form templates, study-specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides, and training materials • Identify training needs for CRAs and third-party vendors and present training at Investigator Meetings and Study Kick-off meetings • Generate potential site lists and drive site feasibility • Identify enrollment risks and develop country recruitment and retention strategies • Coordinate 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 the FAQ log • Support planning and conduct of investigator meetings • Review and/or approve investigational product release packages • Oversee submissions and approvals to Competent Authorities and IRB/Ethics Committees • Develop clinical monitoring strategies and ensure study timelines and quality deliverables • Generate and use metric reporting, including CTMS, data-management query trends, and outstanding monitoring reports • Implement and manage the eTMF • Develop and implement CAPA plans with PM, CRAs, and QA • Assist sites, internal staff, and CRAs with GCP audit preparation • Coordinate project-specific resourcing issues with the PM • Escalate CRA performance and site compliance issues • Collaborate with data management and CRAs to ensure data quality and data-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 • Negotiate site budgets and investigator contracts as needed • Review site visit reports and ensure monitoring is conducted according to the monitoring plan • Manage clinical vendors as needed • Perform clinical data review of patient profiles, data listings, and summary tables, including query generation • Potentially manage direct reports • Perform other duties assigned by management

🎯 Requirements

• 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) • 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, delegation, 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 • Excellent communication, organizational, presentation, analytical, interpersonal, time management, decision-making, and critical-thinking skills

🏖️ Benefits

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