IRT System Designer

Randstad
 Irvine, CA

job summary:

As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that aims to develop treatments for difficult-to-cure diseases. This renowned employer has created 32 products, including Humira and Lupron, that have highly impacted lives across the globe. If you're looking to stand out in your field and lead the way to innovative therapies, this position is for you!

location: Irvine, California

job type: Contract

salary: $47.49 - 55.87 per hour

work hours: 9 to 5

education: Bachelors

responsibilities:

Our Data Science is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation. This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences.

  • Ensures that the requirements of each study protocol are reflected in systems designs and that common data standards are used
  • Ensures that systems are specified to optimize on functionality, end user experience, and data flow
  • Accountable for the on-time design and delivery of new clinical systems, integrations between systems, as well any required changes to clinical systems (e.g., EDC, IRT,). Utilizes project management tools to track study progress and plan work. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions
  • Ensures that TA- and program-level consistency is achieved
  • Interacts with and influences DSS and cross-functional team members to achieve program and study objectives. Ensures that assigned work product is synchronized with upstream and downstream dependencies
  • Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures(SOPs), and to functional quality standards. Stays abreast of new and/or evolvinglocal regulations, guidelines and policies related to clinical development

qualifications:

  • Bachelors degree and 3+ years of IRT experience
  • Experience in the biopharma industry/clinical research with knowledge of ICH/GCP practices
  • Experience drafting and updating IRT specification requirements documentation
  • Experience in project management of IRT systems (from initial build to study closure)
  • Experience writing IRT system test scripts and facilitating/leading UAT testing efforts
  • Ability to manage competing priorities and management of multiple ongoing assignments at one time

skills: SOP, GCP (Good Clinical Practice), ICH Regulations

For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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