Clinical Data Management Specialist

bioMérieux•Salt Lake City, UT

20h•Hybrid

About The Position

Work independently and closely with both internal and external clinical trials partners such as Clinical Scientists (CS), Biostatisticians, Internal labs and clinical sites personnel. Review the Clinical Trial (CT) or associated studies documents from data capture, retrieval and handling perspectives. Understand data management needs and work closely with the CS to define the user requirements specifications. Build and maintain clinical databases (including specific programs) as per the pre-defined specifications. Use existing or set-up ad hoc new tools and processes for retrieving data. Follow appropriate verification and validation procedures to make the final database and retrieval tools ready to use. Define the monitoring requirements in collaboration with the CS and Biostatisticians if necessary. Review the monitoring strategy and develop or execute existing programs and set-up appropriate ad hoc tools as needed for the purpose of customized monitoring reports or equivalent, or basic statistical analysis. Collect, handle, and review data and manage queries along the CT or associated studies, as per responsibilities defined with the CS in the monitoring strategy. Prepare and proactively communicate reporting to team members, including basic statistical analyses as needed. Freeze and customize databases for the purpose of statistical analysis. Organize closure activities, ensuring appropriate clinical study data storage, final quality and integrity following applicable procedures and regulation. Provide daily support for solving any tools or processes related issues and develop customized technical solutions as appropriate. Contribute to departmental projects for tools and processes' continuous improvement and life cycle management in close collaboration with end-users, and by considering new strengthen environment (including regulations). Telecommuting may be permitted. When not telecommuting, must report to bioMérieux, Inc. at 515 Colorow Drive, Salt Lake City, Utah 84108.

Requirements

Bachelor’s degree or U.S. equivalent in Life Science, Bioinformatics, Statistics, Computer Science, Data Management, or a related field
2 years of professional experience as a Clinical Data Engineer, Clinical Data Management Director, or any occupation, job title, position managing large data sets (including clinical and research data)
2 years of professional experience handling data management outputs at the service of the clinical trials and working as a clinical affairs team member
2 years of professional experience working with relational databases including SQL language, Cloud solution, and Tableau
2 years of professional experience collecting user requirements for creating databases and reports
2 years of professional experience working with database management systems (DBMS) (including Medidata, Medrio, and Veeva Vault)
1 year of professional experience working with Excel and using advanced functionalities including VBA coding and Power Query

Responsibilities

Work independently and closely with both internal and external clinical trials partners such as Clinical Scientists (CS), Biostatisticians, Internal labs and clinical sites personnel
Review the Clinical Trial (CT) or associated studies documents from data capture, retrieval and handling perspectives
Understand data management needs and work closely with the CS to define the user requirements specifications
Build and maintain clinical databases (including specific programs) as per the pre-defined specifications
Use existing or set-up ad hoc new tools and processes for retrieving data
Follow appropriate verification and validation procedures to make the final database and retrieval tools ready to use
Define the monitoring requirements in collaboration with the CS and Biostatisticians if necessary
Review the monitoring strategy and develop or execute existing programs and set-up appropriate ad hoc tools as needed for the purpose of customized monitoring reports or equivalent, or basic statistical analysis
Collect, handle, and review data and manage queries along the CT or associated studies, as per responsibilities defined with the CS in the monitoring strategy
Prepare and proactively communicate reporting to team members, including basic statistical analyses as needed
Freeze and customize databases for the purpose of statistical analysis
Organize closure activities, ensuring appropriate clinical study data storage, final quality and integrity following applicable procedures and regulation
Provide daily support for solving any tools or processes related issues and develop customized technical solutions as appropriate
Contribute to departmental projects for tools and processes' continuous improvement and life cycle management in close collaboration with end-users, and by considering new strengthen environment (including regulations)

Benefits

A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
Company-Provided Life and Accidental Death Insurance
Short and Long-Term Disability Insurance
Retirement Plan including a generous non-discretionary employer contribution and employer match
Adoption Assistance
Wellness Programs
Employee Assistance Program
Commuter Benefits
Various voluntary benefit offerings
Discount programs
Parental leaves