Clinical Data Manager

🔥 0 minutes ago

🌐 Mexico, Brazil, +4 more countries – Remote

🇲🇽 Mexico – Remote 🇧🇷 Brazil – Remote 🇦🇷 Argentina – Remote 🇨🇴 Colombia – Remote 🇨🇱 Chile – Remote 🇵🇪 Peru – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🧪 Clinical Research

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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

• Manage all aspects of the clinical trial data management process from study start-up through post-database lock for assigned projects • Follow SOPs/WIs, regulatory directives, study-specific plans, and guidelines • Serve as primary Data Management contact and Lead DM for assigned clinical projects/programs • Oversee project data entry, including guidelines, training, quality, and resourcing • Assess timelines and resource needs and ensure data management deadlines are met with quality • Develop CRF specifications from clinical study protocols and coordinate stakeholder review • Assist with clinical database builds and conduct database build UAT • Maintain quality-controlled database build documentation and oversee clinical database quality • Specify and oversee edit check and manual data review requirements • Create, revise, version, and maintain data management documentation and oversee Trial Master File completeness • Train clinical research personnel and data management project team members • Review and query clinical trial data according to the Data Management Plan • Perform line-listing data review and patient/study status and metric reporting • Perform medical coding and coordinate SAE/AE reconciliation • Liaise with third-party data and EDC vendors regarding timelines and data-related deliverables • Troubleshoot operational problems using metrics, audit reports, and stakeholder input • Participate in SOP/process documentation, protocol/SAP/CSR reviews, strategy meetings, proposals, estimates, and cross-functional initiatives • Communicate with study sponsors, vendors, and project teams regarding data and database issues • Present software demonstrations, trainings, and project meetings • Perform other assigned duties and occasional travel

🎯 Requirements

• Bachelor’s degree and/or a combination of related experience • 8+ years’ experience for a Senior Clinical Data Manager; 10+ years for a Principal Clinical Data Manager • Proficiency in Microsoft Office: Word, Excel, PowerPoint, and Outlook • Ability to handle a variety of clinical research tasks • Excellent organizational and communication skills • Professional use of English, written and oral • Experience using various clinical database management systems • Broad knowledge of drug, device, and/or biologic development and effective data management practices • Strong representational, leadership, and interpersonal skills • Ability to undertake occasional travel • Preferred: experience in a clinical, scientific, or healthcare discipline • Preferred: dictionary medical coding using MedDRA and WHODrug • Preferred: understanding of CDISC standards, including CDASH, SDTM, and ADaM • Preferred: oncology and/or orphan drug therapeutic experience