Clinical Trial Protocol Specialist, Digital Trial Solutions
ConcertAI is looking for an experienced Clinical Trial professional to work with the top sponsors 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.
- Work with pharma, CROs and oncology research networks to optimize study design with the intent of creating digitally regulatory ready studies.
- 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.
- Train and support internal users on use of the clinical trial optimization software suite and the digital trial solution suite.
- Demonstrated experience in the clinical trial development process (oncology preferred).
- Strong customer communication skills and ability to work collaboratively using remote tools.
- Ability to write product requirements to address issues/enhancements identified in collaboration with customers to the product management team.
- Familiarity with agile development and concepts such as databases, programming, statistical modeling, machine learning, data visualization.