Position Overview

The Senior Clinical Data Associate is a hybrid role (3 days onsite/2 days remote) role with responsible for coordinating and overseeing all aspects of Clinical Data Management activities. This includes supporting design, development, validation, implementation, maintenance, and close-out of clinical databases. Work closely with Clinical Operations and external vendors and ensure quality of clinical data. Job duties:
  • Develop Data Management Plan (DMP), maintain DMP throughout lifecycle of study project and ensure DMP is followed according to study design and methodologies.
  • Collaborate with external CRO for database programming to establish timely delivery of the clinical database setup and participate in User Acceptance Test (UAT).
  • Ensure specifications for the electronic data (i.e., angiography, ultrasounds, etc.) are created and provided to external vendors.
  • Participate in the development of EDC custom reports.
  • Coordinate and/or provide training on data management system and tools.
  • Oversee data management vendor performance, quality and deliverables.
  • Serve as the data management representative on study and report the timelines, issues and risks to internal and external study team and leadership.
  • Perform data quality review and oversee data cleaning activities.
  • Author, review and/or approve data management study documents (e.g. eCRF specifications, annotated CRFs Edit Check specifications, eCRF completion Guidelines, Data Transfer Plans, etc.) and ensure documents are maintained and ready for regulatory submission and inspection.
  • Performs additional responsibilities as assigned.

    1. Bachelor’s Degree in a biological science, health-related, or computer science field.
    2. A minimum of two (2) years of experience as a Clinical Data Sr. Specialist, or a combination of data management experience and college courses in a related field may be considered.
    3. Experience in medical device and/or pharmaceutical clinical research or health services industry.
    Desired Qualifications
    1. Demonstrated knowledge of clinical trial process and medical terminology.
    2. Good understanding of the clinical database life cycle including CRF design, database development and testing, query management and data quality review and database lock procedures.
    3. Adept at problem solving, numerical abilities and analytical skills.
    4. Experience in working with CROs/EDC vendors for data management activities.
    5. Excellent written and verbal communication skills.
    6. Proficient with MS Word, Excel and Outlook.
    7. Knowledge of ICH GCP guidelines.