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Informed Consent Specialist

Icon Plc
ICON PLC
4-8 years
preferred by company
Bangalore, Chennai, Trivandrum, India
2 May 18, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance, Clinical Trials, Functional Teams, Literature Review, Management Skills, Medical Information, Medical Records, Medical Strategy, Pharmacovigilance, Regulatory Compliance, Risk Management, Safety Scien, Coaching Skills, Data Science, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Pro, Collaboration, Communication Skills, gmp, GMP Guidelines, Operational Excellence, Problem Solving Skills, Quality Agreements, Quality Compliance, Quality Management, Quality Standards, Regulatory Requ, Communication Skills

Informed Consent Specialist

Location: Bangalore / Chennai / Trivandrum, India
Company: ICON plc
Job Type: Full-Time
Work Mode: Office With Flex (Hybrid)
Department: Clinical Research / Study Start-Up / Site Activation
Job Reference ID: JR146421

Job Overview

ICON plc is hiring an Informed Consent Specialist (ICF Specialist) for its clinical research operations team in India. This role is ideal for experienced professionals with expertise in Informed Consent Form (ICF) writing, clinical trial start-up, ethics committee submissions, regulatory compliance, and site activation processes.

As an ICF Specialist, you will be responsible for creating, reviewing, approving, and managing Subject Information Sheets (SIS) and Informed Consent Forms (ICFs) for global and country-specific clinical trials. This position plays a critical role in ensuring ethical compliance, patient safety, and successful clinical trial initiation.

This opportunity is highly suitable for professionals looking to grow in clinical trial start-up, regulatory documentation, site activation, ethics submissions, and global clinical operations.

Key Responsibilities

Informed Consent Form Development

  • Prepare, review, and approve:
    • Global master ICF templates
    • Country-specific ICF versions
    • Site-specific informed consent adaptations
    • Subject Information Sheets (SIS)

Ensure content accuracy, clarity, and regulatory compliance.

Regulatory & Compliance Management

Ensure all ICF documentation aligns with:

  • ICH-GCP guidelines
  • ICON SOPs / Work Procedures
  • Local country regulations
  • Ethics Committee (EC) requirements
  • Institutional Review Board (IRB) requirements
  • Competent Authority (CA) regulations

Maintain audit-ready documentation standards.

Ethics Committee / IRB Query Resolution

  • Review regulatory comments and queries related to ICFs
  • Negotiate and resolve EC / IRB / CA feedback
  • Ensure timely approval of informed consent documentation

Clinical Trial Start-Up Support

  • Support study activation and start-up documentation workflows
  • Collaborate with study start-up teams to ensure timelines are met
  • Forecast approval timelines and identify risks proactively

Stakeholder Collaboration

Work closely with:

  • Sponsors
  • SSU Project Managers
  • Clinical Trial Managers
  • Regulatory teams
  • Site Activation teams
  • Ethics submission stakeholders
  • Internal cross-functional teams

Act as a key point of contact for ICF-related activities.

Trial Master File Documentation

  • Ensure completeness and accuracy of ICF documents
  • Transfer approved documents into Trial Master File (TMF)
  • Maintain document traceability and compliance

Subject Matter Expertise

  • Stay updated on changing global informed consent regulations
  • Provide process expertise on ICF compliance
  • Support internal knowledge sharing and best practices

Training & Mentorship

  • Train new team members
  • Support onboarding activities
  • Conduct internal training on ICF processes and compliance

Audit & Inspection Support

  • Represent the department during:
    • Audits
    • Inspections
    • Compliance reviews
    • Cross-functional governance meetings

Required Qualifications

Bachelor’s degree in:

  • Life Sciences
  • Pharmacy
  • Biotechnology
  • Biomedical Sciences
  • Healthcare
  • Clinical Research
  • Related scientific field

Experience Required

Total Experience: 4 to 8 years

Mandatory:

  • 4–8 years in:
    • Clinical trial feasibility
    • Study start-up
    • Site activation

Must Have:

  • Minimum 2+ years of direct ICF writing / ICF development experience