Senior Clinical Data Manager

🔥 16 minutes ago

🌐 Mexico, Brazil, +1 more countries – Remote

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

• Manage all aspects of clinical trial data management from study start-up through post-database lock for assigned projects • Serve as primary Data Management contact and Lead Data Manager for assigned clinical projects/programs • Oversee data entry processes, including guidelines, training, quality, resourcing, and quality control • Assess and manage timelines, deadlines, and resource needs • 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 and data management documentation, including Trial Master File completeness • Specify and oversee edit checks and manual data review specifications • 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-level status and metric reporting • Perform medical coding and coordinate SAE/AE reconciliation • Liaise with third-party data and EDC vendors regarding timelines and deliverables • Identify and troubleshoot operational problems using metrics, audit reports, and stakeholder input • Participate in SOP/process documentation development and maintenance • Communicate with study sponsors, vendors, and project teams regarding data and database issues • Provide leadership for cross-functional and organization-wide initiatives • Participate in meetings, presentations, proposals, project estimates, software demonstrations, and trainings • May assist with SAS programming and quality control of SAS programs • May require some travel • 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, Outlook • Ability to handle a variety of clinical research tasks • Excellent organizational and communication skills • Professional use of the English language, 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, leadership, and interpersonal skills • Ability to undertake occasional travel • Preferred: experience in a clinical, scientific, or healthcare discipline • Preferred: dictionary medical coding (MedDRA and WHODrug) • Preferred: understanding of CDISC standards (CDASH, SDTM, ADaM, etc.) • Preferred: oncology and/or orphan drug therapeutic experience • Candidates must be legally authorized to work in the country of employment without employer sponsorship

🏖️ Benefits

• Equal Opportunity Employer • Reasonable accommodation available for applicants with disabilities • Remote work arrangement • Some travel may be required