Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Sr Clinical Data Associate

Thermo Fisher Scientific
Thermo Fisher Scientific
3-7 years
Not Disclosed
10 May 27, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description: Data Cleaning Specialist

Summarized Purpose:

The Data Cleaning Specialist performs all aspects of the data cleaning process, ensuring compliance with Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs)/Work Process Documents (WPDs). They assess the safety and efficacy of investigational products and/or medical devices with minimal supervision.

Essential Functions:

  1. Study Setup Support:

    • Assist in setting up study activities, including database design, testing of data entry screens, and creation of Data Validation Manuals (DVM), as necessary.
  2. Data Review and Quality Check:

    • Review data listings to ensure accuracy and consistency of data.
  3. Specialized Process Expertise:

    • Act as the point person and subject matter expert for specialized study-specific processes.
  4. Data Clarifications and Query Resolution:

    • Generate, track, and resolve data clarifications and queries.
    • Make changes to the clinical database as required.
  5. Process Improvement:

    • Contribute to the enhancement of data management processes on a global level.
  6. Reporting:

    • Produce project-specific status reports for management and/or clients regularly.
  7. Training and Supervision:

    • Provide training and work direction to junior staff, as needed.

Education and Experience:

  • Education: Bachelor's degree or equivalent, along with relevant formal academic/vocational qualifications.
  • Experience: Previous experience equivalent to 3 - 7 years, providing the necessary knowledge, skills, and abilities to perform the job effectively.

This structured format provides a clear outline of the essential functions, educational requirements, and experience necessary for the Data Cleaning Specialist role.