Clinical Database Associate

Hayward, CA, United States
Sep 25, 2020
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Summary

The Clinical Database Associate will collaboratively support Clinical Affairs, and external vendors to ensure that clinical data is collected, managed, and organized in a timely manner that adheres to strict clinical policy. This position will wear many hats and work collaboratively and cross-functionally with many departments within Pulse.

Essential Duties and Responsibilities
  • Create and test study data collection modules (e.g., CRFs, databases, etc).
  • Create study annotations and data listings.
  • Develop scripts to maintain and resolve database issues.
  • Review and validate data verification.
  • Enter study data into appropriate databases.
  • Design, build, and conduct edit checks against data.
  • Execute and review the results of data verification and cleaning scripts.
  • Review, query, and resolve outstanding data entry issues.
  • Work with CRAs and site coordinators on study data issues.
  • Develop and execute UATs.
  • Complete EDC guidelines for sites.
  • Develop and implement customer-defined study closeout procedures.
  • Assist in the development of data standards and workflows for Data Management department.
  • Attend data management meetings and share work progress.
  • Prepares periodic and specialized data reports and data listing.
  • Manage user accounts.
  • Trains sites on how to use EDC.
  • Other duties as assigned.

Education and Experience
  • Bachelor's Degree in Clinical, Clinical Data, IT, or related field.
  • 3+ years' experience in clinical data.
  • GCP certificate highly desired .

Skills, Abilities, and Other Requirements
  • Proficient knowledge of:
    • MS Office Suite applications
    • Clinical Data Collection
    • IT and Systems Integration
    • cGMP
    • Windows OS
  • Proficient knowledge of JavaScript is highly desirable.
  • Excellent oral written communication skills and critical thinking skills.
  • Ability to work well independently (self-starter) and as part of a team and adaptable
  • Ability to take direction and execute accordingly
  • Ability to articulate technical challenges internally and to external study-related personnel
  • Excellent organizational, analytical and debugging skills
  • Must be able to review and understand medical/technical data
  • Ability to give and receive feedback

Human Resources