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Informed Consent Specialist (Icf Specialist)

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ICON
4-8 years
Not Disclosed
Bangalore, Chennai, Trivandrum, India
2 May 7, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: 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, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs

Informed Consent Specialist (ICF Specialist)

Location: Bangalore, India / Chennai, India / Trivandrum, India
Work Mode: Office With Flex
Job Type: Full-Time
Experience Required: Minimum 4–8 Years in Clinical Research, Site Activation, or Clinical Trial Start-Up
ICF Experience Required: Minimum 2+ Years in Informed Consent Form (ICF) Writing & Development
Industry: Clinical Research / Pharmaceutical / CRO


Job Overview

We are seeking an experienced and detail-oriented Informed Consent Specialist (ICF Specialist) to support the development, review, approval, and regulatory compliance of informed consent documentation for global clinical trials. The selected candidate will play a critical role in ensuring ethical clinical trial conduct by managing Subject Information Sheets (SIS), Informed Consent Forms (ICFs), and country-specific consent documentation in alignment with regulatory standards and clinical research guidelines.

This role is ideal for professionals with expertise in clinical trial start-up, informed consent development, regulatory compliance, and ethics committee coordination within pharmaceutical, biotechnology, or CRO environments.


Key Responsibilities

ICF Development & Review

  • Develop, review, and approve:
    • Subject Information Sheets (SIS)
    • Informed Consent Forms (ICFs)
    • Global master templates
    • Country-specific consent forms
    • Site-specific adaptations
  • Ensure informed consent documentation is:
    • Accurate
    • Regulatory compliant
    • Ethically aligned
    • Submission-ready
  • Support timely clinical trial study start-up activities.

Regulatory Compliance & Ethics Oversight

  • Apply strong knowledge of:
    • ICH-GCP guidelines
    • ICON SOPs/WPs
    • Country-specific regulations
    • Ethics committee requirements
  • Review and resolve:
    • Ethics Committee (EC) queries
    • Institutional Review Board (IRB) feedback
    • Competent Authority (CA) comments
      related to ICF submissions and approvals.

Stakeholder Collaboration

  • Serve as a key point of contact for:
    • Sponsors
    • Clinical Trial Managers
    • Site Start-Up teams
    • SSU Project Managers
    • Functional stakeholders
  • Coordinate with cross-functional teams to:
    • Optimize project timelines
    • Ensure regulatory alignment
    • Support successful study initiation
  • Maintain effective communication across global project teams.

Timeline & Risk Management

  • Forecast and monitor:
    • SIS approval timelines
    • ICF submission timelines
    • Regulatory review progress
  • Identify potential risks and implement contingency plans to minimize delays in study start-up activities.
  • Ensure timely completion of documentation and approvals.

Documentation & TMF Management

  • Ensure accurate filing and transfer of ICF-related documentation into:
    • Trial Master Files (TMF)
    • Regulatory repositories
    • Study documentation systems
  • Maintain complete and audit-ready clinical documentation throughout the study lifecycle.

Knowledge Leadership & Mentorship

  • Act as a Subject Matter Expert (SME) for informed consent and regulatory compliance topics.
  • Stay updated with:
    • Evolving regulatory requirements
    • Country-specific language regulations
    • Ethical research standards
  • Provide:
    • Training sessions
    • Knowledge-sharing support
    • Mentorship for new hires and junior team members.

Audit & Inspection Support

  • Represent the department during:
    • Audits
    • Inspections
    • Cross-functional meetings
    • Governance committees
  • Ensure compliance with:
    • Clinical trial standards
    • Regulatory requirements
    • Internal quality procedures.

Required Qualifications

Educational Qualifications

Preferred Qualification:

  • Bachelor’s Degree or Master’s Degree in:
    • Life Sciences
    • Pharmacy
    • Biotechnology
    • Clinical Research
    • Healthcare
    • Nursing
    • Or related scientific disciplines

Experience Requirements

Required Experience

  • Minimum 4–8 years of experience in:
    • Clinical Trial Start-Up
    • Feasibility & Site Activation
    • Clinical Research Operations
    • CRO or Pharmaceutical environments
  • Minimum 2+ years of hands-on experience in:
    • ICF Writing
    • Informed Consent Development
    • Regulatory document preparation

Preferred Experience

  • Experience in:
    • Protocol review and interpretation
    • Ethics committee coordination
    • Regulatory submissions
    • TMF management

Freshers are not eligible for this role.