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Associate Clinical Db Val Mgr

4-6 years
Not Disclosed
10 April 8, 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

 

Job Title: Associate Clinical DB Validation Manager

Company: IQVIA

Location: Kochi, India

Job Type: Full-time

Job ID: R1473775


Job Overview:

Responsible for managing validation projects for clinical databases, ensuring quality deliverables are produced on time and within budget. Provides leadership, planning, and oversight to testing teams while ensuring compliance with regulatory guidelines, SOPs, and CDM processes.


Key Responsibilities:

Project Oversight & Planning:

  • Attend Kick-Off and regular project meetings until Study Go Live

  • Own and manage the creation of the Edit Checks Test Plan

  • Assign and review test cases for validation

  • Review project plan and escalate any issues

  • Ensure documentation updates (e.g., Test Plans, ASB, Edit Specifications) are recorded and version-controlled

Technical & Quality Oversight:

  • Test email alerts, validate system configuration (AUL, Rights/Roles, etc.)

  • Ensure eCRF and Time & Events QC per checklist

  • Review Testing Comments Log and provide feedback to programmers

  • Monitor documentation compliance in eDMSF

Stakeholder Management:

  • Coordinate with internal stakeholders and functional managers to ensure proper resourcing

  • Provide validation status updates to Data Team Leads and Lead Programmers

  • Serve as the main point of contact for internal customers regarding validation deliverables

Leadership & Strategic Initiatives:

  • Lead and mentor validation team members

  • Manage project financials, budgets, and track out-of-scope activities

  • Conduct quality reviews and implement quality management plans

  • Contribute to continuous improvement processes and technological implementation

  • Act as Subject Matter Expert (SME) within the validation group


Qualifications:

  • Degree: Bachelor’s in Science, Computer Science, Information Technology, or Technology (Required)

  • Experience:

    • 4–6 years of relevant clinical database testing experience on CDMS platforms

    • Total experience: 6+ years (Required)


Key Skills:

  • Clinical Data Management Systems (CDMS)

  • Test planning and execution

  • eCRF validation, edit check creation, and system configuration

  • Project and stakeholder management

  • Budgeting and financial tracking

  • Documentation compliance and audit readiness

  • Team mentoring and process improvement


About IQVIA:

IQVIA is a global leader in clinical research services, real-world data analytics, and technology solutions for the life sciences industry. Their mission is to drive healthcare forward by combining deep industry expertise with innovative technology.
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