Business Analyst

1 month ago


Bethesda, United States Themesoft Inc. Full time

Job Title: Business Analyst with clinical data background, good client management skills.

Location: Bethesda, MD (On-Site)

Duration: Full Time


Job Responsibilities:

  • Assist in translation of clinical study requirements into trial Casebook.
  • Develop and maintain Data Management Plans in areas such as data workflow and data transfers.
  • Develop edit check specifications for the automated cleaning of data management practices and procedures (SOPs, Work Instructions), including identifying and recommending solutions for technology issues.
  • Conduct user acceptance testing of study databases, reports, study notifications and database customizations. Resolve problems with databases.
  • Develop study specific data listings.
  • Identify opportunities for improvement and proposed solutions, develop procedures and train to new processes.
  • Experience utilizing Electronic Data Capture systems (OpenClinica), Veeva Vault eTMF, and SAS.
  • Mentor junior team members in the roles and responsibilities of the Clinical Data Management Analyst. Train participating staff on technical procedures and software usage.

Required Qualifications

  • Minimum 5 years in a clinical or medical or research setting.
  • Bachelors degree required- Education and work experience in computer science, life sciences or technical field.
  • Expert in data collection best practices for clinical trials.
  • Expert knowledge of global clinical operations.
  • Expert in the use of SQL to query data sets based on defined parameters.
  • Certified Clinical Data Manager (CCDM) or equivalent would be great but not required
  • Good Customer Handling skills.

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