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20 days old

Clinical Data Manager

WIRB-Copernicus Group (WCG)
Boston, MA 02109

General Information

Location: Boston, MA

Organization: Analgesic Solutions

Description and Requirements

The Clinical Data Manager will be responsible to analyzes clinical trial data using Analgesic Solutions' Central Statistical Surveillance System and Service (QDSS). QDSS is used to look for aberrant signals in data that may indicate a problem that could affect a trial's outcome. The Clinical Data Manager works with subject matter experts to evaluate the relevance of signals and recommend analysis-driven interventions. They will also recommend and implement new tools and processes to improve the analysis pipeline and the visualization of data signals, and will present data to study sponsors and gathers feedback from them on the results of interventions.  Internally, we call this position Senior Clinical Data Analyst.


Location:

  • Our home office is located in Wayland, MA, but our next hire may work remote.  Applicants located on the east coast are preferred

Education Requirements:

  • Bachelors Degree in Biology, Chemistry, Mathematics, Statistics or similar field
  • A degree in biostatistics is preferred

Qualifications:

  • 7 years in a clinical field or environment
  • 3 years experience in Clinical Data Analysis
  • Skilled in the areas of clinical data sets, clinical trial protocols, and FDA, ICH, and GCP guidelines
  • Experience working in the clinical research industry is required
  • Thorough understanding of cross-functional clinical processes including data management and biostatistics
  • Knowledge of development environment, classification, analytical and other software
  • Skilled in SQL programing, as it relates to this position, is required
  • Working knowledge of Python, R, etc., is preferred
  • Experience with data mining and visualization tools such as Tableau, Spotfire, R, etc. is preferred
  • Ability to work in teams and collaborate with others to clarify requirements
  • Strong written and verbal communication skills
  • Excellent critical thinking, organization and prioritization skills

Essential Duties / Responsibilities:

  • Identify, manage and analyze aberrant clinical trial data signals from Analgesic Solutions' Quantitative Data Surveillance System (QDSS)
  • Recommend interventions to address any clinically relevant aberrancies, may include collaborating and consulting with subject matter experts.
  • Provide ongoing analysis on data trends and results to improve the efficiency of data management and the algorithms used for analysis
  • Member of the Data Science and Technology group, testing and providing clinical guidance into the development piece.
  • Work with others in the Data Science and Technology group to implement applications, tools, and processes for data management and data analysis using Analgesic Solutions' systems.
  • Identify opportunities to innovate and improve product and the companys capabilities 
  • Provide clinical expertise and guidance to all stages of development, from product ideation through architecture, documentation, implementation, testing, and support

ABOUT US:

Analgesic Solutions, LLC., founded in 2006, is a privately held company that reduces the risks in clinical trials through consulting, innovative tools, data science, technology and training. With hundreds of projects completed and ongoing collaborations with regulatory authorities, Analgesic Solutions is the premier choice for mitigating risk associated with measurement error in clinical trials, central statistical monitoring, and specialized training.

Categories

Posted: 2020-10-08 Expires: 2020-11-12

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Clinical Data Manager

WIRB-Copernicus Group (WCG)
Boston, MA 02109

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