Technical Study Designer (Home-based, Mexico) - IQVIA Biotec

Technical Study Designer (Home-based, Mexico) - IQVIA Biotec

22 feb
|
IQVIA Argentina
|
México

22 feb

IQVIA Argentina

México

Technical Study Designer (Home-based, Mexico) - IQVIA Biotech



Primary Location: Mexico City, Mexico Full time R1141110 Date Posted: 08/12/2020



IQVIA Biotech is seeking a Technical Study Designer for a home-based opportunity Mexico City, Mexico!



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.



#LI-BN3



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 .

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