Clinical Data Manager

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 will enable rapid growth and continued support of our mission. Our teams work remotely and have access to our offices in Colorado, New York, and Portugal. 

Cleerly is creating 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. 

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.

Working at Cleerly takes HEART. Discover our Core Values:

• H: Humility- be a servant leader
• E: Excellence- deliver world-changing results
• A: Accountability- do what you say; expect the same from others
• R: Remarkable- inspire & innovate with impact
• T: Teamwork- together we win

Why you should apply:

• PURPOSE: Cleerly’s purpose is to create a world without heart attacks. With our new paradigm for precision heart care, we will leave big footprints in the sands of time. Help us make that a reality!
• GROWTH: We prioritize learning and growth. As a rapid growth company, there is always space for new challenges and responsibilities.
• OWNERSHIP: Everyone on the team contributes to our success, so everyone has equity in the company through our employee stock option incentive plan.
• BENEFITS: Cleerly offers a variety of medical, dental, and vision plans, designed to fit you and your family’s needs. Along with stock options and a 401(k) match program that helps you invest in the future, Cleerly also offers company wide holidays, a winter break, as well as a self-managed PTO policy. Additional benefits include, wellness, home office and learning & development stipends and parental leave benefits for new parents.

Don’t meet 100 percent of the qualifications? Apply anyway and help us diversify our candidate pool and workforce. We value experience, whether gained formally or informally on the job or through other experiences.

OUR COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER.  We do not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law, ordinance, or regulation.

Job duties, activities and responsibilities are subject to change by our company.

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