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Senior Technical Study Designer (Office or Home-Based) - Novella Clinical (R1053828) in Morrisville, NC at IQVIA™

Date Posted: 12/3/2018

Job Snapshot

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

BASIC FUNCTIONS:

Design of data collection forms and data validation checks within an electronic data capture (EDC) system for the purpose of 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.
  • Ability to train other staff.

    MINIMUM RECRUITMENT STANDARDS:

  • Degree in computer or biological/life sciences with a minimum of 5 years of work experience as a lead data manager or lead EDC programmer.
  • Excellent interpersonal and organizational skills required.
  • Experience with web page and database design required.

    CLASSIFICATION:

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

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

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™



Job ID: R1053828