Senior Technical Study Designer (Europe, Home-based) - IQVIA Biotech

IQVIA 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

CLASSIFICATION:

This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.

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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 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.