{"id":1080915,"url":"https://alion.io/job/bd-clinical-systems-specialist","title":"Clinical Systems Specialist","company":{"id":1821,"name":"BD","domain":"bd.com","url":"https://alion.io/company/bd","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":86,"open_postings":40,"ghost_share":0,"stale_share":0.55,"repost_share":0,"time_to_fill_p50_days":31,"computed_at":"2026-10-20T05:45:00Z"}},"role":"Science & Research","role_family":"Science & Research","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Sparks, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":65000,"max_usd":140000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":870},"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":true},{"name":"GDPR","optional":true},{"name":"HIPAA","optional":true},{"name":"Microsoft Office","optional":true},{"name":"Power BI","optional":true},{"name":"SharePoint","optional":true}],"status":"live","first_seen_at":"2026-09-20T21:58:39Z","employer_posted_date":"2026-09-20","last_verified_at":"2026-10-20T11:06:24Z","board_verified":true,"closed_at":null,"days_open":29,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":29},"description":"As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.\n\nWe are the people who give possibilities purpose\nBD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.\n\nJob Description\nClinical Systems Specialist\nAbout Clinical Systems Architecture\nThe Clinical Systems Architecture team is dedicated to advancing the development and commercialization of new products by delivering scalable, compliant, and inspection-ready clinical systems. We lead the implementation, optimization, and strategic direction of clinical technology solutions that improve efficiency, automation, and interoperability across clinical development and medical affairs.\nOur mission is to streamline clinical operations, optimize trial execution, and ensure harmonized processes and systems from study startup through closeout. Through innovative solutions, strategic partnerships, and a commitment to quality, we enable teams to focus on accelerating the development and delivery of products that improve patient care.\nPosition Summary\nThe Clinical Systems Specialist is responsible for supporting and optimizing clinical operations systems, with a primary focus on Veeva eTMF and Veeva CTMS. This role serves as a key resource for system administration, configuration, user support, training, reporting, and continuous improvement initiatives that enable efficient and compliant execution of clinical studies.\nWorking collaboratively with Clinical Operations, Data Management, Medical Affairs, Quality, Regulatory Affairs, and Information Technology, the Clinical Systems Specialist ensures eTMF and CTMS solutions are effectively configured, maintained, and utilized to support inspection readiness, operational excellence, and business objectives. The individual will play an important role in driving system adoption, supporting TMF health initiatives, and promoting best practices across clinical teams.\nEssential Duties and Responsibilities\nClinical Systems Administration & Support\nAdminister and support Veeva eTMF and Veeva CTMS, including user account provisioning, role configuration, access management, and periodic access reviews.\n\nServe as a primary point of contact for end-user support, troubleshooting system issues and coordinating resolutions with internal and external partners.\n\nMonitor system performance, usability, and data quality to identify opportunities for improvement.\n\nSupport system releases, upgrades, enhancements, and configuration changes.\n\nMaintain system documentation, including configuration records, work instructions, and training materials.\n\nClinical Operations Systems Configuration\nConfigure and maintain system objects, workflows, reports, dashboards, metadata, and user permissions to support clinical operations processes and business requirements.\n\nAssist with implementation of new system functionality and enhancements.\n\nSupport testing activities, including user acceptance testing, validation documentation, and defect tracking.\n\nExecute data loads, bulk updates, and data remediation activities using available system tools and utilities.\n\nSupport system integrations and data exchange processes where applicable.\n\neTMF & CTMS Operations\nSupport TMF health, completeness, quality, and inspection-readiness initiatives across clinical studies.\n\nAssist with maintaining TMF structures, metadata standards, filing conventions, and document management processes.\n\nMonitor CTMS data quality and support study, site, milestone, and operational tracking activities.\n\nGenerate reports, dashboards, metrics, and key performance indicators to support study teams and management decision-making.\n\nPartner with Clinical Operations and study teams to ensure consistent and compliant use of eTMF and CTMS platforms.\n\nSupport TMF reviews, reconciliation activities, and ongoing readiness for audits and regulatory inspections.\n\nTraining & User Adoption\nDevelop and deliver training for new and existing system users.\n\nCreate job aids, quick reference guides, and other support materials.\n\nPromote best practices and drive system adoption through proactive engagement with stakeholders.\n\nProvide guidance on system capabilities and opportunities to improve business processes.\n\nContinuous Improvement\nIdentify opportunities for workflow automation, process simplification, and operational efficiencies.\n\nParticipate in cross-functional initiatives related to clinical systems and process improvements.\n\nAssist in evaluating new technologies and capabilities that enhance clinical operations effectiveness.\n\nStay current on industry trends, regulatory expectations, and emerging best practices related to eTMF, CTMS, and clinical trial technology.\n\nCompliance & Quality\nEnsure system-related activities are performed in accordance with company procedures, regulatory requirements, and quality standards.\n\nSupport computerized system validation activities and associated documentation.\n\nMaintain compliance with applicable regulations and industry standards.\n\nSupport audit and inspection activities as required.\n\nEducation and Experience\nRequired\nBachelor's degree in Life Sciences, Clinical Research, Information Systems, Healthcare Administration, or a related field.\n\nMinimum of 2 years of experience in Clinical Operations, Clinical Systems, Medical Affairs Operations, TMF Management, or related functions.\n\nMinimum of 2 years of experience supporting, administering, or configuring eTMF and/or CTMS platforms.\n\nExperience working in a regulated GxP environment.\n\nPreferred\nExperience with Veeva Vault eTMF and/or Veeva CTMS.\n\nExperience supporting TMF health initiatives, TMF remediation, or inspection readiness activities.\n\nExperience supporting system implementations, upgrades, migrations, or enhancements.\n\nVeeva Vault certification(s) preferred but not required.\n\nKnowledge, Skills, and Abilities\nTechnical Skills\nRequired\nExperience supporting, configuring, or administering clinical systems, preferably eTMF and/or CTMS platforms.\n\nExperience with user management, role-based security, reporting, dashboards, workflows, and system configuration.\n\nExperience performing data maintenance activities, including bulk updates, data imports, and data quality reviews.\n\nAbility to analyze business processes and identify opportunities for system optimization and automation.\n\nExperience developing user documentation, training materials, and standard operating procedures.\n\nProficiency with Microsoft Office applications, including Excel, PowerPoint, Teams, and SharePoint.\n\nPreferred\nExperience supporting Veeva Vault eTMF and/or Veeva CTMS.\n\nExperience configuring Vault documents, objects, lifecycles, workflows, dashboards, and reporting capabilities.\n\nFamiliarity with system integrations, APIs, and data exchange processes.\n\nExperience utilizing Power Query, Power BI, or similar tools for data analysis and reporting.\n\nUnderstanding of software validation and change control processes within regulated environments.\n\nRegulatory & Industry Knowledge\nWorking knowledge of:\nICH Good Clinical Practice (ICH-GCP)\n\n21 CFR Part 11\n\nHIPAA\n\nGDPR\n\nDIA TMF Reference Model\n\nGAMP 5\n\nSoftware Development Lifecycle (SDLC)\n\nClinical trial documentation and inspection-readiness principles\n\nCore Competencies\nStrong analytical and problem-solving skills\n\nExcellent organizational skills and attention to detail\n\nStrong written and verbal communication skills\n\nAbility to manage multiple priorities and deadlines effectively\n\nStrong customer service orientation and stakeholder management skills\n\nAbility to work independently while collaborating effectively across functions\n\nContinuous improvement mindset with a focus on efficiency, quality, and compliance\n\nAt Waters, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.\nFor certain roles, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.\nWhy Join Us?\nTo find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.\nWe believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.\nTo learn more about BD visithttps://bd.com/careers.\nBecton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.\nRequired Skills\nOptional Skills\n.\nPrimary Work Location\nUSA MD - Sparks - 7 Loveton CircleAdditional Locations\nWork Shift\n\nAt BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under \" Our Commitment to You.\"\nOur salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.\nOur pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. 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