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Clinical Data Management Associate

2+ years
Not Disclosed
10 April 17, 2025
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

 


Clinical Data Management Associate

Position Summary:
The Clinical Data Management Associate is responsible for providing expert skills as part of the clinical data management team within the Data Management and Statistics Department. The role ensures that efficient and high-quality data management products are produced in accordance with customer requirements. Core responsibilities include maintaining clinical data review, query review, and resolution in alignment with study timelines while upholding the quality and integrity of clinical trial data.

Responsibilities:

  • Manage delivery of projects through the full data management lifecycle, including:

    • Annotated CRF development

    • Management of queries and warnings

    • Processing of external data

    • Reporting

    • SAE reconciliation

    • Updating data in the eCRF

    • Coding activities (development, validation, oversight of coding library)

    • Coding review (MedDRA, CTCAE, WHO, or Sponsor dependent)

    • Validation or participation in UAT

    • Development of eCRF guidelines

  • Review SAS program outputs for queries

  • Provide input on:

    • eCRF development according to Sponsor needs and protocol specifications

    • Project timelines

    • Quality issues

    • Resource management

  • Perform presentations on data management activities

  • Manage comprehensive data management tasks according to documented project specifications

  • Provide data management expertise and suggest process improvements to the Lead Clinical Data Manager or Principal Clinical Data Manager

  • Comply with the Company’s Quality and Information Security Management Systems and applicable national and international legislation, including data protection laws

Professional Experience Requirements:

  • Up to 2 years of experience in specialized data management skills (e.g., CRF design, SAE reconciliation, central laboratory management, or new technologies) within a CRO, pharmaceutical, or equivalent organization

Application:
Interested candidates can apply by sending their resume to:
mahendra.t3705@veedalifesciences.com