Senior Technical Study Designer - IQVIA Biotech
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
This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.
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.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.
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 email@example.com to arrange for such an accommodation.
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