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Icf Manager – Clinical Research & Medical Affairs

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ICON
4+ years
Not Disclosed
Remote, USA, Remote
3 May 7, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, 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.

ICF Manager – Clinical Research & Medical Affairs

Company: ICON plc
Job Title: ICF Manager
Location: Remote – United States
Job Type: Full-Time
Industry: Clinical Research / CRO / Pharmaceutical
Experience Required: 4+ Years
Travel Requirement: 5–10% International & Domestic Travel


Job Overview

ICON plc is hiring an experienced ICF Manager to support global clinical research operations and informed consent documentation processes. In this role, you will lead the end-to-end management of Master Informed Consent Forms (ICFs) while ensuring compliance with global regulatory requirements, study protocols, and sponsor standards.

The role is embedded within a pharmaceutical company environment and focuses on improving workflow efficiency, reducing turnaround times, and ensuring high-quality patient-facing documentation across clinical studies.


Key Responsibilities

ICF Development & Management

  • Develop and manage study-level Master Informed Consent Forms (ICFs) from draft creation to final approval.
  • Ensure informed consent documents comply with:
    • Study protocols
    • Regulatory standards
    • Schedules of assessments
    • Global compliance requirements
  • Support country-specific and site-specific ICF reviews and amendments.
  • Coordinate review cycles and approval workflows with:
    • Clinical Study Managers (CSM)
    • CRO partners
    • SSU Managers
    • Cross-functional stakeholders
  • Maintain proper filing and documentation within the Trial Master File (TMF).

Regulatory Compliance & Documentation

  • Ensure compliance with:
    • ICH-GCP guidelines
    • US CFR regulations
    • EU CTD standards
    • Global clinical trial regulations
  • Assist with:
    • Audit follow-ups
    • CAPA activities
    • Regulatory inspections
    • Documentation quality reviews
  • Support process improvement initiatives related to ICF workflows and compliance management.

Stakeholder Collaboration & Project Coordination

  • Lead ICF kick-off meetings and facilitate communication across teams.
  • Collaborate with:
    • Sponsors
    • CROs
    • Clinical operations teams
    • Regulatory teams
    • Vendors
  • Manage timelines, workflow tracking, and issue resolution for ICF deliverables.
  • Identify project risks and implement mitigation strategies where required.

Required Qualifications

Educational Qualification

  • Bachelor’s Degree or equivalent qualification required.
  • Preferred background in:
    • Life Sciences
    • Clinical Research
    • Healthcare
    • Nursing
    • Pharmacy

Preferred Qualifications

  • RN (Registered Nurse)
  • Master’s Degree
  • Doctorate
  • Clinical or patient-facing documentation experience

Experience Requirements

Mandatory Experience

  • Minimum 4+ years of experience in:
    • Pharmaceutical industry
    • Clinical research
    • CRO environments
  • Minimum 2+ years of direct experience in:
    • Study Start-Up (SSU)
    • Informed Consent Form (ICF) development
    • ICF management workflows

Preferred Experience

  • Experience working at:
    • Sponsor level
    • CRO level
    • Clinical trial sites
  • Experience with:
    • Veeva systems
    • TMF documentation
    • Clinical document management

Freshers Eligibility

  • This role is not for freshers.
  • Strong prior experience in clinical documentation and ICF workflows is mandatory.

Required Skills

Clinical & Regulatory Skills

  • ICF Development & Review
  • Clinical Documentation Management
  • Study Start-Up Operations
  • Regulatory Compliance
  • TMF Management
  • Audit Readiness
  • CAPA Management
  • Protocol Interpretation

Technical Skills

  • Microsoft Office Suite
  • Document Management Systems
  • Veeva Vault (Preferred)
  • Workflow Coordination Tools

Soft Skills

  • Strong organizational skills
  • Excellent written and verbal communication
  • Cross-functional collaboration
  • Problem-solving and risk management
  • Ability to work independently in remote environments

Why Join ICON plc

  • Work with a globally recognized CRO and healthcare intelligence company
  • Opportunity to contribute to high-impact global clinical trials
  • Flexible remote working environment
  • Exposure to international regulatory processes
  • Collaborative and innovation-driven culture
  • Strong professional growth opportunities in clinical operations and regulatory documentation