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Clinical Data Manager

2 months ago

Thousand Oaks, United States Aditi Consulting Full time

Job Title: Biomedical Data Stewardship Mgr

Location: Remote

Duration: 12 months contract (Potential to extend)


Position/Role/Title: Data Manager, Standardization


Ideal candidate:

• Metadata, database, programming with knowledge of pharmaceutical industry data standards

• 4 or more years of pharmaceutical/biotech experience in drug development

• Master’s degree with relevant experience as defined above.


What you will do

In this role we are looking for individuals with metadata, database, and programming expertise, a quantitative science background (data science, computer science, mathematics, or similar), and a passion for drug development. The candidate for this role will work within the Biomedical Data Stewardship (BMDS) team here at. This role will have an opportunity to work across pipeline to participate in and lead the maintenance, extraction, consolidation, analysis, and presentation of complex internal and external clinical trial data standards. The role will provide opportunities to develop leadership skills and utilize standardization methods to drive clinical development strategy.


In this role you will:

• Build a comprehensive understanding of data standards structure across stages of development

• Build a comprehensive understanding of the Metadata Repository (MDR) product and design, and identify areas for improvement and expansion

• Update and maintain data standards metadata

• Develop integrations with the MDR enabling visualization of the standards, compliance reporting, and metrics

• Use SAS Enterprise Guide to develop and maintain SAS programs to extract Data Element Standards and to create datasets, reports, and workbooks

• Use data analytics software such as R and R Shiny, Tableau, etc. to develop software solutions and data visualizations


What we expect of you


Basic Qualifications:

• Master’s degree and 3 years quantitative science experience OR

• Bachelor’s degree and 5 years quantitative science experience

• Knowledge of pharmaceutical industry data standards

• Good understanding of clinical trials and clinical data

• Proficient in SAS programming language

• Proficient in R programming language and Shiny app development


Preferred Qualifications:

• Master’s degree with relevant experience

• 4 or more years of pharmaceutical/biotech experience in drug development

• Experience working with pharmaceutical industry data standards

• Excellent SAS and/or R computing, modeling, and visualization skills

• Experience working with multiple relevant programming languages (for example, JavaScript, CSS, Python, VBA, etc.)

• Proven project leadership experience

• Independent and self-motivated

• Strong organizational skills such that facilitate multi-tasking in time-sensitive environments

• Strong communication and collaboration skills


Top 3 Must Have Skill Sets:

Ideal candidate:

• Metadata, database, programming with knowledge of pharmaceutical industry data standards

• 4 or more years of pharmaceutical/biotech experience in drug development

• Master’s degree with relevant experience as defined above.

• Advanced Data Management and Programming Skills

• Deep understanding of Clinical Study Standards

• Analytical and Troubleshooting Expertise



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