Clinical Systems Specialist
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Job Description
Clinical Systems Specialist
About Clinical Systems Architecture
The 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.
Our 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.
Position Summary
The 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.
Working 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.
Essential Duties and Responsibilities
Clinical Systems Administration & Support
Administer and support Veeva eTMF and Veeva CTMS, including user account provisioning, role configuration, access management, and periodic access reviews.
Serve as a primary point of contact for end-user support, troubleshooting system issues and coordinating resolutions with internal and external partners.
Monitor system performance, usability, and data quality to identify opportunities for improvement.
Support system releases, upgrades, enhancements, and configuration changes.
Maintain system documentation, including configuration records, work instructions, and training materials.
Clinical Operations Systems Configuration
Configure and maintain system objects, workflows, reports, dashboards, metadata, and user permissions to support clinical operations processes and business requirements.
Assist with implementation of new system functionality and enhancements.
Support testing activities, including user acceptance testing, validation documentation, and defect tracking.
Execute data loads, bulk updates, and data remediation activities using available system tools and utilities.
Support system integrations and data exchange processes where applicable.
eTMF & CTMS Operations
Support TMF health, completeness, quality, and inspection-readiness initiatives across clinical studies.
Assist with maintaining TMF structures, metadata standards, filing conventions, and document management processes.
Monitor CTMS data quality and support study, site, milestone, and operational tracking activities.
Generate reports, dashboards, metrics, and key performance indicators to support study teams and management decision-making.
Partner with Clinical Operations and study teams to ensure consistent and compliant use of eTMF and CTMS platforms.
Support TMF reviews, reconciliation activities, and ongoing readiness for audits and regulatory inspections.
Training & User Adoption
Develop and deliver training for new and existing system users.
Create job aids, quick reference guides, and other support materials.
Promote best practices and drive system adoption through proactive engagement with stakeholders.
Provide guidance on system capabilities and opportunities to improve business processes.
Continuous Improvement
Identify opportunities for workflow automation, process simplification, and operational efficiencies.
Participate in cross-functional initiatives related to clinical systems and process improvements.
Assist in evaluating new technologies and capabilities that enhance clinical operations effectiveness.
Stay current on industry trends, regulatory expectations, and emerging best practices related to eTMF, CTMS, and clinical trial technology.
Compliance & Quality
Ensure system-related activities are performed in accordance with company procedures, regulatory requirements, and quality standards.
Support computerized system validation activities and associated documentation.
Maintain compliance with applicable regulations and industry standards.
Support audit and inspection activities as required.
Education and Experience
Required
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.
Preferred
Experience with Veeva Vault eTMF and/or Veeva CTMS.
Experience supporting TMF health initiatives, TMF remediation, or inspection readiness activities.
Experience supporting system implementations, upgrades, migrations, or enhancements.
Veeva Vault certification(s) preferred but not required.
Knowledge, Skills, and Abilities
Technical Skills
Required
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.
Preferred
Experience supporting Veeva Vault eTMF and/or Veeva CTMS.
Experience configuring Vault documents, objects, lifecycles, workflows, dashboards, and reporting capabilities.
Familiarity with system integrations, APIs, and data exchange processes.
Experience utilizing Power Query, Power BI, or similar tools for data analysis and reporting.
Understanding of software validation and change control processes within regulated environments.
Regulatory & Industry Knowledge
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)
Clinical trial documentation and inspection-readiness principles
Core Competencies
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
Strong customer service orientation and stakeholder management skills
Ability to work independently while collaborating effectively across functions
Continuous improvement mindset with a focus on efficiency, quality, and compliance
At 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.
For 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.
Why Join Us?
To 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.
We 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.
To learn more about BD visithttps://bd.com/careers.
Becton, 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.
Required Skills
Optional Skills
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Primary Work Location
USA MD - Sparks - 7 Loveton CircleAdditional Locations
Work Shift
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Our 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.
Our 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. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.
Salary Range Information