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