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Technical Operations Analyst

Role overview

Qualifications

  • 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

Responsibilities

  • Collaborate with PM and IT to define requirements for project-specific system set-up and validation
  • Serve as a subject matter expert (SME) in project-specific discussions regarding clinical systems needs
  • Perform functional testing and provide support during user acceptance testing (UAT)
  • Support Quality Assurance and IT with study and system level audit trail review needs from an Operations standpoint

Key facts

Hard skills

Other skills

  • Collaboration
  • Problem Solving
  • Communication
  • Teamwork

About the company

CTI Clinical Trial and Consulting Services logo

CTI Clinical Trial and Consulting Services

Contract Research Organizations (CRO)

CTI Clinical Trial and Consulting Services is a global, privately held, full-service contract research organization (CRO), delivering a complete spectrum of clinical trial and consulting services throughout the lifecycle of development, from concept to commercialization. CTI’s focused therapeutic approach provides pharmaceutical, biotechnology, and medical device firms with clinical and disease area expertise in rare diseases, regenerative medicine/gene therapy, immunology, transplantation, nephrology, hematology/oncology, neurology, infectious diseases, hepatology, cardiopulmonary, and pediatric populations. CTI also offers a fully integrated multi-specialty clinical research site that conducts phase I-IV trials. CTI has a passion for helping life-changing therapies succeed in chronically and critically ill patient populations. With clinical trial experience across 6 continents, CTI partners with research sites, patients, and sponsors to fulfill unmet medical needs. CTI is headquartered in Cincinnati, OH, with operations across North America, Europe, Latin America, and Asia-Pacific. For more information visit www.ctifacts.com

Company details

IndustryContract Research Organizations (CRO)
Company size1001 - 5000

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Job description

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.

Important Note
In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.

Please Note

  • We will never communicate with you via Microsoft Teams or text message
  • We will never ask for your bank account information at any point during the recruitment process

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Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
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