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- Senior Technical Study Designer (EU, Home-Based) - IQVIA Biotech
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Senior Technical Study Designer (EU, Home-Based) - IQVIA Biotech
IQVIA Holdings Inc.
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.
Job posted: 2021-02-25