Clinical Systems Specialist
WEP Clinical, Morrisville, NC, United States
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.
The Ideal Candidate:
Strategic
Technical
Detail Oriented
Strong Communicator
What You’ll Do:
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.
What You’ll Need:
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.
What We Offer:
Medical, dental, and vision insurance, FSA, HSA
Voluntary short-term and long-term disability insurance
Voluntary life insurance
401K safe harbor plan and company match
Paid vacation, holiday, and sick time
Paid maternity & paternity leave
What Sets Us Apart:
WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.
We're Committed to Our Team:
WEP has many initiatives to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events, and all that we do to support our employees.
We're Committed to DEI:
At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone's unique identities.
Our services include:
Access Programs
Clinical Trial Services
Patient Site Solutions
Clinical Trial Supply
Market Access and Commercialization
WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.
WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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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.
The Ideal Candidate:
Strategic
Technical
Detail Oriented
Strong Communicator
What You’ll Do:
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.
What You’ll Need:
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.
What We Offer:
Medical, dental, and vision insurance, FSA, HSA
Voluntary short-term and long-term disability insurance
Voluntary life insurance
401K safe harbor plan and company match
Paid vacation, holiday, and sick time
Paid maternity & paternity leave
What Sets Us Apart:
WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.
We're Committed to Our Team:
WEP has many initiatives to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events, and all that we do to support our employees.
We're Committed to DEI:
At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone's unique identities.
Our services include:
Access Programs
Clinical Trial Services
Patient Site Solutions
Clinical Trial Supply
Market Access and Commercialization
WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.
WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
#J-18808-Ljbffr