Clinical Data Specialist

About Cleerly

We’re Cleerly – a healthcare company that’s revolutionizing how heart disease is diagnosed, treated, and tracked. We were founded in 2017 by one of the world’s leading cardiologists and are a growing team of world-class engineering, operations, medical affairs, marketing, and sales leaders. We raised $223M in Series C funding in 2022 which has enabled rapid growth and continued support of our mission. In December 2024 we received an additional $106M in a Series C extension funding. Most of our teams work remotely and have access to our offices in Denver, Colorado, New, York, New York, Dallas, Texas, and Lisbon, Portugal with some roles requiring you to be on-site in a location. 

Cleerly has created a new standard of care for heart disease through value-based, AI-driven precision diagnostic solutions with the goal of helping prevent heart attacks. Our technology goes beyond traditional measures of heart disease by enabling comprehensive quantification and characterization of atherosclerosis, or plaque buildup, in each of the heart arteries. Cleerly’s solutions are supported by more than a decade of performing some of the world’s largest clinical trials to identify important findings beyond symptoms that increase a person’s risk of heart attacks. 

At Cleerly, we collaborate digitally and use a wide variety of systems. Our people use Google Workspace (GMail, Drive, Docs, Sheets, Slides), Slack, Confluence/Jira, and Zoom Video, prior experience in these areas is a plus. Role or department specific technology needs may vary and will be listed as requirements in the job description. 

About the Opportunity

We have a current opening for a Clinical Data Specialist in our Scientific Affairs group. This position reports directly to the Senior Director of Biometrics.

 

TTC*: $148,000 - $159,000

 *Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.). We hire employees anywhere within the United States and account for geography when determining base salary.

 

Responsibilities

Informatics Project Management

• • Lead the development of data management protocols, case report forms (CRFs) and instructions, queries, procedure/in service manuals, project-specific standard operating procedures, and other data management tools for the assigned clinical trials/registries/research studies. Participate in the development and implementation of policies and procedures as needed.
  • Prepare a variety of narrative and analytical reports and correspondence to Principal and Site investigators and staff; monitor adherence to established timelines and recommend corrective action as necessary.
  • Develop study and educational materials; conduct educational or monitoring visits regarding data management to assure utilization of standardized methodologies for CRF completion; assess adherence to protocols, recommend additional training as needed to sites.
  • Develop processes and tools for management of event adjudication for research studies. Provide data management support for event adjudication activities.
  • Provide input and feedback to leadership regarding data requirements, data ascertainment, and quality control and assurance for internal use and site use. Detect deficiencies and implement corrective action needed; follow up and completely resolve detected deficiencies.

Technical/Analytics

• • Liaise with clinical research staff, biostatisticians, Core Lab staff and investigators at sites to support data transfers, data reconciliation and analysis dataset generation.
  • Assist in the development of analysis datasets (working to pull in and clean/harmonize data from disparate sources) and prepare data for extraction and analysis
  • Engage and collaborate with stakeholders in cross-functional teams (Core Lab, Med Affairs, Data Science, Engineering) in the development of artifacts defining the workflow and technical specifications in support of complex and/or novel clinical research projects.
  • Develop, generate, resolve, and track data queries to assure the integrity of the clinical data with respect to data guidelines and specifications.
  • Develop and maintain a working knowledge of statistical principles and analysis considerations taken into account during planning of research projects
  • Generate data exports from databases via the development and execution of SQL queries.
  • Lead the implementation, migration and validation of research data systems.
  • Build data management tools (eCRFs, data validation, queries) within various data management products (e.g., REDCap, Medrio, Qualtrics, Excel).
  • Perform mapping of data structures