Technical Operations Analyst

CTI Clinical Trial and Consulting Services; Lisboa; Hybrid; EUR 42,000 - 59,000; Full time

Benefits offered by this job

Hybrid work from home opportunities

Tuition reimbursement

Mentoring program

Leadership courses

Paid parental leave

Job summary

CTI Clinical Trial and Consulting Services is seeking a qualified professional to support clinical systems across projects. You will collaborate with PMs and IT to define requirements, validate setups, and ensure ongoing maintenance while educating Operations staff on processes.

Key responsibilities include SME input on system needs, assisting with UAT and access controls, and supporting CTMS administration and audit trail reviews to improve efficiency.

Qualifications

• Bachelor’s degree in allied health fields or equivalent education/work experience.
• At least 2 years of experience in clinical research related field.
• Hands-on end-user experience with CTI clinical systems (e.g., Medidata RAVE, CTMS, RTSM, Merative Zelta, Salesforce provisioning).

Responsibilities

• Collaborate with PM and IT to define requirements for project-specific system set-up and validation.
• Collaborate with IT and PMs to ensure proper set-up and maintenance of clinical systems; educate Operations team as needed.
• Serve as a SME in project discussions regarding clinical systems needs.
• Support UAT, user access checks, and system maintenance across projects.
• Maintain CTMS data and assist QA/IT with audit trail reviews.

Skills

Clinical systems familiarity

End-user experience in clinical trials

Vendor coordination and IT liaison

Education

Bachelor’s degree in allied health fields such as nursing, pharmacy, or health / natural science

Tools

Medidata RAVE

CTMS

RTSM

Merative Zelta

Salesforce Account Provisioning

Job description

• Collaborate with PM and IT to define requirements for project-specific system set-up and validation; review project-specific validation documentation
• Collaborate with IT and PMs to ensure proper set-up and maintenance of clinical systems; educate Operations team as needed on processes/requirements
• Serve as a subject matter expert (SME) in project-specific discussions regarding clinical systems needs
• Participate in system core team meetings and vendor oversight meetings with IT system owners
• Perform functional testing and provide support during user acceptance testing (UAT), as needed
• Conduct periodic user access checks and reconciliation across clinical system platforms for projects
• Field inquiries from project staff regarding use of clinical systems/serve as clinical system SME from Operations perspective; collaborate with IT to troubleshoot technical issues
• Support project-specific system maintenance, as needed
• Support the management and account provisioning of user access requests to clinical systems for projects, as needed
• Support the CTMS Admin team with the maintenance of system-level information in CTMS, as needed
• Support Quality Assurance and IT with study and system level audit trail review needs from an Operations standpoint
• Support the adaptation of Artificial Intelligence (AI) solutions to create efficiencies and process improvements
• Participate in discussions regarding the creation of tools and reports to support efficient clinical systems related processes
• Participate in the development and maintenance of clinical system training and reference materials

What You’ll Do

• Collaborate with PM and IT to define requirements for project-specific system set-up and validation; review project-specific validation documentation
• Collaborate with IT and PMs to ensure proper set-up and maintenance of clinical systems; educate Operations team as needed on processes/requirements
• Serve as a subject matter expert (SME) in project-specific discussions regarding clinical systems needs
• Participate in system core team meetings and vendor oversight meetings with IT system owners
• Perform functional testing and provide support during user acceptance testing (UAT), as needed
• Conduct periodic user access checks and reconciliation across clinical system platforms for projects
• Field inquiries from project staff regarding use of clinical systems/serve as clinical system SME from Operations perspective; collaborate with IT to troubleshoot technical issues
• Support project-specific system maintenance, as needed
• Support the management and account provisioning of user access requests to clinical systems for projects, as needed
• Support the CTMS Admin team with the maintenance of system-level information in CTMS, as needed
• Support Quality Assurance and IT with study and system level audit trail review needs from an Operations standpoint
• Support the adaptation of Artificial Intelligence (AI) solutions to create efficiencies and process improvements
• Participate in discussions regarding the creation of tools and reports to support efficient clinical systems related processes
• Participate in the development and maintenance of clinical system training and reference materials

What You’ll Bring

• Bachelor’s degree in allied health fields such as nursing, pharmacy, or health / natural science or an equivalent combination of education and relevant work experience
• At least 2 years of experience in clinical research related field
• Hands-on end-user experience and knowledge of various clinical systems utilized by CTI (e.g., Medidata RAVE, CTMS and RTSM, Merative Zelta, Salesforce Account Provisioning, etc.)

About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com

Why CTI?

• Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
• Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.
• Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.