Technical Study Designer - IQVIA Biotech

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