Clinical Data Management Specialist
bioMerieux Inc., Salt Lake City, UT, United States
Clinical Data Management Specialist (bioMerieux, Inc., Salt Lake City, UT)
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 for 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 strength environment (including regulations). Telecommuting may be permitted. When not telecommuting, must report to bioMerieux, Inc. at 515 Colorow Drive, Salt Lake City, Utah 84108.
Education and Experience Qualifications
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)
Must also have experience in the following: 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); and 1 year of professional experience working with Excel and using advanced functionalities including VBA coding and Power Query
The estimated salary range for this role is between $75,000-$107,000. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux's bonus program.
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
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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 for 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 strength environment (including regulations). Telecommuting may be permitted. When not telecommuting, must report to bioMerieux, Inc. at 515 Colorow Drive, Salt Lake City, Utah 84108.
Education and Experience Qualifications
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)
Must also have experience in the following: 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); and 1 year of professional experience working with Excel and using advanced functionalities including VBA coding and Power Query
The estimated salary range for this role is between $75,000-$107,000. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux's bonus program.
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
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