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IQVIA Senior Technical Study Designer (EU, Home-Based) - IQVIA Biotech in Stevenage, United Kingdom

QVIA Biotech is seeking a Senior Technical Study Designer for a home-based opportunity!

BASIC FUNCTIONS:

Design of data collection forms and data validation checks within an electronic data capture (EDC) system for conducting clinical trials. Coordinate tasks and resource allocation for a given project under the supervision of a manager of Project Programming. Develop training materials and assist with the development of data collection work practices as needed.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Interpret the study protocol for design in EDC.

  • Create study build timeline with input from internal and sponsor teams.

  • Plan and conduct internal and sponsor team meetings for determining data collection requirements and for review of study designs.

  • Design and update data collection forms based on study protocol requirements, corporate standards, best practices, and feedback from internal and sponsor study teams.

  • Create and update data validation edit check specifications based on study protocol requirements, corporate standards, best practices, and feedback from internal and sponsor teams.

  • Coordinate edit checks and custom function programming with programming leads.

  • Deploy study design to test and production environments.

  • Communicate any project risks to the project manager, including the potential for missing a planned timeline and working outside of the original budget or scope-of-work expectations.

  • Escalate potential quality issues to management.

  • Comply with all training and standard operating procedures (SOPs) for the position.

  • Responsible for multiple study design projects at the same time.

  • May work on projects across multiple trial EDC platforms.

  • Identify areas for process improvement and actively participate in process improvement initiatives as assigned by manager.

  • Train and support junior Technical Study Designers to ensure they have necessary skills to meet their deliverable.

  • Support and develop standards ensuring alignment with other functional groups associated with EDC workspace.

KNOWLEDGE, SKILLS AND ABILITIES:

  • Knowledge of clinical research process and methodology.

  • Knowledge and understanding of current GCP, ICH, and FDA guidelines and regulations applicable to conduct of clinical research.

  • Ability to supervise resources and plan tasks for EDC development with the support of management.

  • Ability to work creatively and independently to carry out assignments of a complex nature.

  • Ability to manage multiple project timelines and regularly switch between projects as required to meet timeline deliverable expectations.

  • Ability to communicate and work effectively and cooperatively with fellow employees and with sponsors.

  • Ability to learn new programming languages, technology, and tools that will facilitate the clinical trial process.

  • Excellent interpersonal and organizational skills required.

  • Ability to train other staff.

MINIMUM RECRUITMENT STANDARDS:

  • Bachelor’s degree in computer or biological/life sciences

  • 5 years of work experience as a lead data manager or lead EDC programmer

  • Experience with web page and database design preferred

  • Equivalent combination of education, training and experience

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At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .

IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

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