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Associate Data Manager - Clinical Data Sciences

2+ years
$64,600.00 to $107,600.00
10 Dec. 27, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

This job description is for an Associate in Clinical Data Management at Pfizer, focusing on processing, reviewing, and managing clinical data and documentation across therapeutic groups and clinical trials. The role is designed to support the timely and accurate collection, validation, and oversight of clinical trial data to ensure quality and compliance with regulatory standards.

Key Responsibilities:

  1. Data Management & Monitoring:

    • Contribute to project milestones and meet task deadlines.
    • Participate in Data Monitoring and Management (DMM) activities including data review and query management.
    • Ensure the design, documentation, testing, and validation of clinical data collection tools and systems.
  2. Customer Support & Issue Resolution:

    • Serve as the primary point of contact for Clinical Trial Management System (CTMS) issues.
    • Investigate discrepancies, identify issues with study documentation, and resolve them in collaboration with study teams.
  3. Regulatory Compliance & Process Improvement:

    • Ensure adherence to SOPs, ICH/GCP guidelines, and regulatory requirements.
    • Contribute to process improvement initiatives within data management.
  4. Collaboration & Reporting:

    • Liaise with various team members to resolve data issues and improve processes.
    • Communicate findings and issues effectively to ensure data quality and consistency.

Qualifications:

  • Must-Have:

    • Bachelor’s Degree.
    • Knowledge of ICH/GCP documentation requirements and clinical trial processes.
    • Hands-on experience with electronic documentation management systems or web-based data management tools.
    • Awareness of clinical development processes, regulatory requirements, and data standards.
    • Strong attention to detail and commitment to excellence.
    • Proficiency in Microsoft Office and strong communication skills.
  • Nice-to-Have:

    • Experience managing medical and clinical study records.

Additional Information:

  • Location: Flexible (work onsite 2-3 days per week).
  • Salary: $64,600 to $107,600 annually.
  • Bonus: Eligible for a 7.5% bonus of base salary.
  • Benefits: Includes health insurance, 401(k), paid time off, and more.
  • Relocation: Not available.

Application Details:

  • Last Date to Apply: January 3, 2025.
  • Referral Bonus: Eligible for Employee Referral Bonus.

Pfizer seeks dedicated individuals to contribute to the success of clinical trials by managing data effectively, ensuring compliance, and supporting the broader clinical research objectives.

This job description is for an Associate in Clinical Data Management at Pfizer, focusing on processing, reviewing, and managing clinical data and documentation across therapeutic groups and clinical trials. The role is designed to support the timely and accurate collection, validation, and oversight of clinical trial data to ensure quality and compliance with regulatory standards.

Key Responsibilities:

  1. Data Management & Monitoring:

    • Contribute to project milestones and meet task deadlines.
    • Participate in Data Monitoring and Management (DMM) activities including data review and query management.
    • Ensure the design, documentation, testing, and validation of clinical data collection tools and systems.
  2. Customer Support & Issue Resolution:

    • Serve as the primary point of contact for Clinical Trial Management System (CTMS) issues.
    • Investigate discrepancies, identify issues with study documentation, and resolve them in collaboration with study teams.
  3. Regulatory Compliance & Process Improvement:

    • Ensure adherence to SOPs, ICH/GCP guidelines, and regulatory requirements.
    • Contribute to process improvement initiatives within data management.
  4. Collaboration & Reporting:

    • Liaise with various team members to resolve data issues and improve processes.
    • Communicate findings and issues effectively to ensure data quality and consistency.

Qualifications:

  • Must-Have:

    • Bachelor’s Degree.
    • Knowledge of ICH/GCP documentation requirements and clinical trial processes.
    • Hands-on experience with electronic documentation management systems or web-based data management tools.
    • Awareness of clinical development processes, regulatory requirements, and data standards.
    • Strong attention to detail and commitment to excellence.
    • Proficiency in Microsoft Office and strong communication skills.
  • Nice-to-Have:

    • Experience managing medical and clinical study records.

Additional Information:

  • Location: Flexible (work onsite 2-3 days per week).
  • Salary: $64,600 to $107,600 annually.
  • Bonus: Eligible for a 7.5% bonus of base salary.
  • Benefits: Includes health insurance, 401(k), paid time off, and more.
  • Relocation: Not available.

Application Details:

  • Last Date to Apply: January 3, 2025.
  • Referral Bonus: Eligible for Employee Referral Bonus.

Pfizer seeks dedicated individuals to contribute to the success of clinical trials by managing data effectively, ensuring compliance, and supporting the broader clinical research objectives.