A central part of Cleerly’s mission is to perform excellent research that is the foundation for our products and also supports our mission to improve cardiovascular health. We have many ongoing and upcoming significant investigator initiated and corporate research projects and interact with many global leaders in the field.

We are seeking a Clinical Data Specialist with 5 years clinical data/research experience, preferably at a top academic medical center or medical device company. He/she will be responsible for data management aspects of clinical trials and research, from review of study design and data collection tools through study closeout, including eCRF design and build, data collection, data cleaning and characterization.

This is a unique opportunity to participate in groundbreaking innovative research and actively shape a dynamic field in medicine. 

 

Major Responsibilities  

• Database Development
• Gather necessary specifications and build databases in approved electronic data capture systems.
• Perform testing to validate databases and prepare them for launch

 

• Data Design, Development, Validation
• Develop utilities to perform data integration and cleaning tasks, including mapping data to project specifications, verification of external data to internal files, identifying data quality problems, and reporting/documenting data nuances and issues

 

• Data Collection and Quality Assurance
• Ensure that research information is collected and stored in a manner that is compliant with regulations/policies and good clinical data management practice.
• Issue queries to sites and manage query resolution processes.
• Troubleshoot errors in data import files and work with sites to resolve.
• Monitor data collected/submitted for research studies for completeness and accuracy; manage data reconciliation for ongoing trials.
• Prepare data quality status reports for internal tracking.
• Escalate critical data quality issues to Senior Clinical Data Specialist

 

• Site Data Management
• Support the development of data management educational and training materials.
• Communicate with research partners on the requirements and specifications for study data and processes.
• Address relevant clinical queries from study sites; contribute to responses regarding study related Health Authorities and IRB questions.

 

Other duties as assigned, including general project/site management and support.

 

Essential Experience/Skills Required  

• Must have 5 years clinical data management experience at a clinical research organization (CRO), academic health center, or Pharma/Biotech/Medical device company; experience participating in cross-functional research teams through all aspects of clinical study conduct
• Must have a B.S. or B.A. in science, technical discipline, or similar domain
• Experience with all data management aspects of clinical research required
• Experience using data profiling methods to analyze data sources highly preferred
• Experience with building clinical research databases required, with a strong preference for experience working with Medrio
• Must possess working knowledge of medical terminology, clinical medicine, clinical trials and GCP concepts
• Must be detail-oriented and meticulous in all aspects of work
• Research experience in an academic health center or CRO with exposure to a team research environment at all levels (senior investigators, nurses, research coordinators, core lab technicians and administrators) required
• Solid computer skills – Proficiency with MS applications including (but not limited to) Word, Excel, Power Point; proficiency with Google applications (Docs, Sheets, Slides) required 
• SQL/SAS programming experience a plus

 

Salary: $100,000-$130,000

 *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.