Clinical Data Manager
| Company | Cleerly |
|---|---|
| Location | New York, NY, USA, Denver, CO, USA |
| Salary | $128000 – $149000 |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior |
Requirements
- 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
- 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
Responsibilities
- Gather necessary specifications and build databases in approved electronic data capture systems.
- Perform testing to validate databases and prepare them for launch
- 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
- 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
- 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.
Preferred Qualifications
- 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
- SQL/SAS programming experience a plus