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

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

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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Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.