Clinical Data Manager

🔥 0 minutes ago

🌐 Argentina, Brazil, +4 more countries – Remote

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

⏰ Full Time

🟠 Senior

🔴 Lead

🧪 Clinical Research

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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 Data Management contact for assigned clinical projects/programs, ensuring continuity, responsiveness, backup coverage, and timely task completion • Oversee data entry processes, including data entry guidelines, training, quality, and resourcing • Provide quality control of data entry as needed • Assess and manage project timelines, deadlines, and resource needs • Develop CRF specifications from clinical study protocols and coordinate stakeholder review • Assist with clinical database builds • Conduct database build UAT and maintain quality-controlled database build documentation • 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 on study-specific CRFs, EDC, and project-related items • Review and query clinical trial data according to the Data Management Plan • Perform line-listing data reviews and patient/study-level status and metric reporting • Perform medical coding to ensure medical logic and consistency • Coordinate SAE/AE reconciliation • Liaise with third-party data and EDC vendors regarding timelines and data deliverables • Assist with SAS programming and quality control of SAS programs as needed • Identify and troubleshoot operational problems using metrics, audit reports, and stakeholder input • Review and provide feedback on protocols, SAPs, and CSRs as required • Participate in developing and maintaining SOPs and process documentation • Participate in strategy meetings, bid defense preparation, capability presentations, and client engagement meetings as needed • Review RFPs, proposals, and provide project estimates as needed • Provide leadership for cross-functional and organization-wide initiatives • Train and ensure adequate training of data management project team members • Communicate with sponsors, vendors, and project teams about data, database, and project issues • Present software demonstrations, training sessions, and project meetings as needed • Travel occasionally as required • Perform other duties as assigned

🎯 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 utilizing various clinical database management systems • Broad knowledge of drug, device, and/or biologic development and effective data management practices • Strong representational skills and ability to communicate effectively orally and in writing • Strong 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