Clinical Systems Specialist

🔥 0 minutes ago

🦀 Maryland – Remote

🦀 Maryland – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

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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BD

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1897

🏥 Healthcare

🏭 Manufacturing

⚕️ Healthcare Insurance

💰 $24M Grant on 2020-07

Healthcare • Manufacturing • Healthcare Insurance

BD (Becton, Dickinson and Company) is a global medical technology company dedicated to advancing the world of health. It focuses on developing innovative technologies, services, and solutions to improve safety and efficiency in healthcare. BD offers a wide range of products including medication management solutions, surgical solutions, cervical cancer screening, drug delivery systems, and laboratory services. The company is also involved in infection risk management and provides advanced clinical insights to enhance patient outcomes. With a commitment to global health sustainability and social investing, BD is a leader in healthcare technology and services worldwide.

📋 Description

• Administer and support Veeva eTMF and Veeva CTMS, including user provisioning, role configuration, access management, and access reviews • Provide end-user support, troubleshoot system issues, and coordinate resolutions • Monitor system performance, usability, and data quality • Support system releases, upgrades, enhancements, configuration changes, testing, validation documentation, and defect tracking • Maintain configuration records, work instructions, training materials, and other system documentation • Configure system objects, workflows, reports, dashboards, metadata, and user permissions • Execute data loads, bulk updates, and data remediation activities • Support system integrations and data exchange processes • Support TMF health, completeness, quality, inspection readiness, reconciliation, audits, and regulatory inspections • Monitor CTMS data quality and support study, site, milestone, and operational tracking • Generate reports, dashboards, metrics, and KPIs for study teams and management • Partner with Clinical Operations and study teams to ensure compliant platform use • Develop and deliver user training, job aids, and quick reference guides • Promote best practices and drive system adoption • Identify workflow automation, process simplification, and operational efficiency opportunities • Participate in cross-functional clinical systems and process improvement initiatives • Evaluate new technologies and stay current on industry trends, regulatory expectations, and best practices • Ensure system activities comply with company procedures, regulatory requirements, and quality standards

🎯 Requirements

• Bachelor's degree in Life Sciences, Clinical Research, Information Systems, Healthcare Administration, or a related field • Minimum of 2 years of experience in Clinical Operations, Clinical Systems, Medical Affairs Operations, TMF Management, or related functions • Minimum of 2 years of experience supporting, administering, or configuring eTMF and/or CTMS platforms • Experience working in a regulated GxP environment • Experience supporting, configuring, or administering clinical systems, preferably eTMF and/or CTMS platforms • Experience with user management, role-based security, reporting, dashboards, workflows, and system configuration • Experience performing data maintenance activities, including bulk updates, data imports, and data quality reviews • Ability to analyze business processes and identify opportunities for system optimization and automation • Experience developing user documentation, training materials, and standard operating procedures • Proficiency with Microsoft Office applications, including Excel, PowerPoint, Teams, and SharePoint • Working knowledge of ICH Good Clinical Practice (ICH-GCP), 21 CFR Part 11, HIPAA, GDPR, DIA TMF Reference Model, GAMP 5, Software Development Lifecycle (SDLC), and clinical trial documentation and inspection-readiness principles • Strong analytical and problem-solving skills • Excellent organizational skills and attention to detail • Strong written and verbal communication skills • Ability to manage multiple priorities and deadlines effectively • Ability to work independently while collaborating effectively across functions

🏖️ Benefits

• Comprehensive Total Rewards program • Reward and recognition opportunities • Competitive compensation and benefits programs • Learning, growth, and development opportunities • Workplace accommodations considered pursuant to applicable law • Flexible work-life balance considerations for remote or field-based positions