Veeva eTMF/CTMS Specialist — Clinical Systems

BD

Sparks Corner (MD)

On-site

USD 100,000 - 140,000

Full time

3 days ago

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Job summary

Waters Corporation is seeking a Clinical Systems Specialist to support and optimize clinical operations systems, with a focus on Veeva eTMF and Veeva CTMS. You will be a key resource for system admin, user support, training, reporting, and continuous improvement across clinical studies.

In this role, you will collaborate with Clinical Operations, Data Management, Medical Affairs, Quality, Regulatory Affairs, and IT to ensure compliant configuration, implementation, and adoption of eTMF/CTMS

Qualifications

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.

Responsibilities

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.
Configure and maintain system objects, workflows, reports, dashboards, metadata, and user permissions to support clinical operations processes.
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.
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.