Clinical Data Manager

Everly Health’s mission is to transform lives with modern, diagnostics-driven care. Headquartered in Austin, Texas, Everly Health is the parent company to Everlywell, offering at-home tests to consumers, Everly Health Solutions, offering complete solutions for diagnostics-driven virtual care at scale, Natalist, offering fertility and pregnancy essentials, and Everly Diagnostics, our CLIA certified and CAP accredited laboratory network. 
We’ve created a new kind of healthcare experience that’s centered around people. Our infrastructure guides the full testing experience with the support of a national clinician network that’s composed of hundreds of physicians, nurses, genetic counselors, PharmDs, and member care specialists. Our solutions enable world-class virtual care through rigorous clinical protocols and best-in-class science, in order to tackle some of healthcare's biggest problems.
Working without appreciable supervision, is responsible for all aspects of data management activities in support of assigned clinical studies. These activities help to ensure high quality data is achieved in support of analysis for regulatory submissions, safety monitoring and publications. Ensures that Good Clinical Practices (GCP), Good Clinical Data Management Practices (GCDMP) and established processes are followed. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises judgment in planning, organizing and performing work; monitors performance and reports status within area of responsibility. Ensures that quality of services meets internal and external customer requirements.

What You'll Do:

• Performs or coordinate all data management activities for assigned studies, as appropriate
• Protocol and Statistical Analysis Plan (SAP) review and input
• Case Report Form (CRF) development and maintenance
• Edit Check specifications development and maintenance
• Data Management Plan development and maintenance
• Data Quality checks and discrepancy management
• Reviews, summarizes and queries  data, identifies trends; prepares data tables for reports
• Study Database setup testing and Edit Check programming testing
• External data handling
• Device reconciliation and tracking for investigational product
• Participate in Post Market Surveillance reporting as appropriate
• Additional study specific activities
• Ensures that all data management activities for assigned studies are completed on time and with high quality
• Communicates effectively with peers, study teams and management as appropriate to support studies and goals
• Leads efforts to improve Data Management processes, as needed/assigned
• Represents the Data Management group at study team meetings and cross-functional task forces
• Trains and mentors other Clinical Data Associates (CDAs) and Clinical Data Coordinators (CDCs)
• Applies and promotes best practices and established standards
• Serves as a liaison between the study team and clinical data operations
• Is a Subject Matter Expert (SME) in most areas within Data Management
• Understands the whole clinical trial process and regulations that apply, engages in relevant professional associations or societies, and seeks continuing education about SJM devices and therapies.
• Communicates and collaborates with all levels of employees, customers, contractors, and vendors.
• Suggest and drafts departmental Standard Operating Procedures (SOPs), Departmental Work Instruction (DWIs), and guidelines.
• Complies with U.S. Food and Drug Administration (FDA) regulations, International Conference on Harmonisation (ICH), ISO 14155, other regulatory requirements, applicable company policies, operating procedures and processes.
• Performs other related duties and responsibilities, as assigned.

Who You Are:

• Comprehensive knowledge of data management practices from protocol design to database development and study closure. 
• Proficiency with using/building EDC databases and Excel.
• Intermediate knowledge of SQL
• General understanding of SAS
• Experience working under Good Clinical Practices, Good Clinical Data Management Practices, and other FDA regulations and guidelines is required. 
• Familiarity with CDISC/CDASH standards. 
• Demonstrated solid oral and written communication skills and analytical/problem-solving skills are essential, as is the ability to clearly communicate basic data management concepts to those outside data management. 
• Must be able to effectively manage multiple projects and timelines. 
• Requires the ability to sit or stand while working on a computer for a long period of time.
• Bachelor's degree in computer sciences or a scientific discipline.
• Minimum of 5 years of experience in a medical device clinical data management position is strongly preferred.
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You'll Love Working Here:
· Venture backed by top-tier firms· The opportunity ahead knows no bounds· Open vacation policy for salaried team members· Front Loaded PTO for hourly team members· Employee discounts· Paid parental leave· Health benefits· 401(k)
NO EXTERNAL RECRUITERS - INDIVIDUAL APPLICANTS ONLY
Everly Health is committed to providing equal employment opportunities in all employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship status, marital status, age, disability, protected veteran status, sexual orientation or any other characteristic protected by law.
HIPAA Disclaimer: This role will be in an environment that has access to protected health information (PHI) and all security standards to protect PHI must be followed.