Wepclinical7mo ago

Clinical Systems Specialist

United States·MorrisvilleFull-Timemid

OtherClinical

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Quick Summary

Overview

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Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives.

Role Objectives:

The Clinical Systems Specialist at WEP Clinical serves as the subject matter expert (SME) for clinical systems within the organization, including but not limited to the Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF), and WEPConnect portal. As a Clinical Systems Specialist, you’ll be responsible for ensuring that systems are optimized, users are supported, and processes are continuously improved. In addition to core system
ownership, this role will support data reporting, visualization, and automation initiatives, leveraging
tools such as Power BI and Power Automate to enhance data-driven decision-making and operational
efficiency. As a Clinical Systems Specialist, you’ll be responsible for ensuring that systems are
optimized, users are supported, and processes are continuously improved.

Strategic

Technical

Detail Oriented

Strong Communicator

Serve as the primary internal point of contact for all clinical systems-related questions, issues, and user requests.

Manage user access, permissions, and troubleshooting across clinical systems for project team members and stakeholders.

Oversee study room setup, modification, and closeout to ensure compliance and consistency with organizational standards.

Partner with project teams to ensure proper setup and ongoing maintenance of system
configurations.

Monitor system usage to identify inefficiencies, gaps, and opportunities for optimization and increased usability.

Recommend, implement, and document process improvements to enhance system efficiency, compliance, and user experience.

Develop and implement automated workflows (e.g., Power Automate) to streamline repetitive
tasks, improve data flow between systems, and enhance operational efficiency.

Develop, update, and distribute internal documentation such as SOPs, job aids, guidance materials, and form templates.

Create and deliver training sessions and materials to ensure consistent and effective system usage across teams.

Support onboarding of new hires requiring access to clinical systems and ensure timely setup and training.

Act as the liaison with external clinical system vendors (e.g., Trial Interactive), managing issue resolution, enhancements, and updates.

Assist with project-specific tasks such as system uploads, data entry, and QC reviews to support ongoing system maintenance

Bachelor’s degree in Life Sciences, Business, Information Systems, or related field (or equivalent experience)

3+ years of experience working with clinical systems such as CTMS and/or eTMF (Trial Interactive experience strongly preferred)

Highly organized, proactive, detail-oriented, and collaborative, with excellent communication skills and a strong understanding of clinical operations technology

Strong understanding of clinical trial processes, GxP requirements, and inspection-readiness practices

Excellent time management and organizational skills, with the ability to prioritize multiple tasks and meet deadlines

Excellent verbal and written communication skills, with the ability to convey complex technical information clearly to diverse audiences

Proven ability to work independently, take initiative, and drive process improvement

Experience with system administration, configuration, or validation of clinical platforms preferred

Experience with data visualization and reporting tools (e.g., Power BI) and workflow
automation tools (e.g., Power Automate) preferred.