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4-6 years
Not Disclosed
10 Dec. 5, 2024
Job Description
Job Type: Full Time Education: BA/BS 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

Clinical Data Associate III (CDA III)

Overview

The Clinical Data Associate III role at Syneos Health is integral to the management and quality assurance of clinical data, ensuring regulatory compliance and supporting the development of groundbreaking therapies. This position involves advanced data management responsibilities, team coordination, and collaboration with cross-functional teams in a globally recognized biopharmaceutical organization.


Key Responsibilities

  • Project Coordination:

    • Maintain awareness of project contracts and scopes of work.

    • Communicate project status updates to Project Managers and other stakeholders.

  • Clinical Data Management:

    • Execute tasks per Clinical Data Management Plans, including User Acceptance Testing (UAT), data discrepancy reviews, and quality control.

    • Handle database design, edit checks, and CRF/eCRF completion guidelines.

    • Manage Serious Adverse Event (SAE) reconciliations, data transfers, and discrepancy resolutions.

  • Documentation and Reporting:

    • File and organize Data Management Study File (DMSF) documents.

    • Create and update specifications, validation listings, and data cleaning reports.

  • Team Collaboration and Training:

    • Train and mentor other Clinical Data Associates.

    • Provide project-specific training to ensure consistency and accuracy.

  • Quality Assurance:

    • Conduct QC reviews, including data mapping and post-migration testing.

    • Perform quality checks for both electronic and paper studies.

  • Cross-Functional Coordination:

    • Work with Safety, Medical Writing, Biostatistics, and other Data Operations teams.

    • Ensure consistency between clinical and external datasets.

  • Continuous Improvement:

    • Stay updated with clinical data management practices and technologies.

    • Contribute to updates in Data Management Plans and trusted processes.


Qualifications

  • Education:

    • Bachelor’s degree in biological sciences, natural sciences, or health-related disciplines.

  • Experience:

    • 4–6 years of clinical data management experience.

    • Hands-on experience with Veeva, RAVE, INFORM, or similar EDC platforms.

    • Familiarity with central lab data, oncology trials, database migrations, and startup processes.

  • Skills:

    • Proficiency in relational database systems, data validation, and clinical practices.

    • Strong organizational, communication, and multitasking abilities.

    • Advanced knowledge of MS Word, Excel, and email applications.


Why Syneos Health?

  • Impactful Work: Contribute to innovative therapies that improve lives globally.

  • Career Development: Benefit from comprehensive training, mentorship, and career progression opportunities.

  • Inclusive Environment: Thrive in a culture that celebrates diversity and authenticity.

  • Global Reach: Be part of a team operating across 110 countries, with exposure to diverse projects and therapeutic areas.


Location: Home-Based, India
Updated: December 2, 2024
Job ID: 24006517

Join Syneos Health to advance your career in clinical data management while making a meaningful difference in the healthcare industry. Apply Today!