Technical Operations Coordinator – Clinical Trials

Illumina | San Diego, CA

Posted Date 9/16/2021
Description

Position Summary:

The Technical Operations Coordinator position is responsible for enabling clinical trial success for Illumina product development. The applicant will partner with internal and external stakeholders to facilitate technical training, troubleshooting, and complaint resolution for clinical trials in support of product development and U.S. and Global regulatory registration. This position serves as a technical liaison during pre- and post-clinical trial activities and will collaborate with broader Product Development Core Team to ensure success at product launch.

Responsibilities:

  • Primary Liaison between the Product Development/R&D, Clinical Affairs, Service Operations and Commercial Learning Services teams to ensure clinical trial success in support of product registration
  • Participate on Product Development Core Teams as the Service Operations representative
  • Coordinate activities for Service team training (FSE/FAS), clinical site equipment installations, site operator training and proficiency
  • Manage clinical trial Service & Support timelines for service team training (FSE/FAS), clinical site equipment installations and site operator training and proficiency
  • Facilitate orders and shipment of required reagents and supplies for service team and site operator training
  • Lead cross-functional technical complaint handling meetings during clinical trial execution
  • Work alongside Field Service Engineers (FSE) and Field Application Scientists (FAS) to contribute technical product knowledge and link feedback to Product Development team as needed
  • Provide feedback to Product Marketing to optimize user guides and field service documentation updates required for product launch
  • Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Requirements:

  • Experience in a startup and/or in a professional services organization highly preferred;
  • Industry experience within in vitro diagnostics (IVD) needed; medical device, pharmaceutical, or biologics experience can substitute in part for IVD experience.
  • Strong written and verbal communication skills; demonstrated ability to organize and present technical information to internal and external audiences.
  • A passion and high level of comfort interacting with customers with excellent presentation skills to groups internally and externally;
  • A strong desire to learn and grow in a rapidly-expanding arm of an established company;
  • Ability to work closely with end users in a consultative, services and/or support capability;
  • Travel as needed

Experience and Education

  • Bachelor’s degree or equivalent in the life sciences or related field required; advanced degree (Master’s or above) preferred.
  • All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

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