Scientific Director, Digital Trial Solutions

Tech King of Prussia, Pennsylvania United States Boston, Massachusetts San Francisco, California Raleigh-Durham, North Carolina


Description

Scientific Director of Clinical Trial Optimization, Digital Trial Solutions

 Role Summary

ConcertAI is looking for an experienced scientist/clinical trial expert to work with top pharmaceutical companies to redefine how clinical studies are designed and executed.  The candidate will work with some of the most advanced clinical development organizations to show how ConcertAI technology can help them reinvent their clinical development process.   This candidate will engage clients from a sales, delivery, and product perspective to optimize the designs of clinical trials using real world evidence data.  They will be experts in clinical trial design and optimization, with deep analytical skills and technical experience using large real world data sets.

Responsibilities

  • Work with pharma, CROs and oncology research networks to optimize study design with the intent of creating digitally regulatory ready studies.
  • In collaboration with customers, use ConcertAI datasets and systems to develop digital study execution packages, including study protocols, study event schedules, and identify code sets for study protocol inclusion and exclusion criteria.
  • Collaborate with the digital trial solution project manager to develop the study project plan for start-up and run support to ensure study timelines are met.
  • Collaborate with the site clinical study coordinator to deploy and execute the study with the research practices ensuring adherence to the protocol.
  • Collaborate with the Digital Trial Solution team to understand study specific needs and goals and develop plans to implement studies.
  • Apply Good Clinical Practice guidelines to the digitalization of clinical trials.
  • Support innovation of the clinical trial optimization and digital trial solution software suite.
  • Support the training of both internal and external users on use of the clinical trial optimization software suite and the digital trial solution suite.

Requirements

  • Graduate Degree (PhD or MPH) in data analytics related to healthcare, oncology, and clinical research.
  • Demonstrated experience in the clinical trial development process (oncology preferred).
  • Strong customer communication skills and ability to work collaboratively using remote tools.
  • Ability to develop clinical trial requirements to address issues/enhancements identified in collaboration with customers writing clinical research study plans and protocols.
  • Familiarity with agile development and concepts such as databases, programming, statistical modeling, machine learning, data visualization.