[Hiring] ICF Manager @ICON plc

Role Description

As a Medical Affairs Coordinator, working as an ICF Manager, exclusively assigned and embedded within a Pharmaceutical Company. In this role, you will take ownership of the end-to-end development and management of Master Informed Consent Forms (ICFs) for clinical trials, ensuring processes are efficient, high-quality, and fully compliant with global regulatory standards. This role plays a key part in streamlining ICF workflows, reducing turnaround times, and supporting study teams to deliver impactful clinical research.

• Provide subject matter expertise in ICF development, using company templates, processes, and systems.
• Prepare study-level Master ICFs from draft to final approval, collaborating with CSM, SSU Manager, CRO, and other stakeholders, and ensure filing in the TMF.
• Support country- and site-specific ICF reviews and manage amendments, including review, approval, and filing.
• Coordinate reviews by functional stakeholders and facilitate ICF kick-off meetings.
• Ensure ICF content aligns with study protocols, schedules of events, and regulatory requirements.
• Act as SME for ICF processes, systems, and workflows, supporting process improvements, training, and language library updates.
• Assist with follow-up to audit findings and CAPAs related to ICFs.

Qualifications

• Ability to interpret study protocols and schedules of assessments to develop accurate ICFs.
• Strong teamwork, organizational, and problem-solving skills, including experience leading cross-functional teams and collaborating with vendors.
• Proficiency in Microsoft Office and document management systems.
• Knowledge of global regulatory and compliance requirements for clinical research (e.g., US CFR, EU CTD, ICH GCP); awareness of local country requirements is an advantage.
• Experience in project or program management, including risk identification and mitigation.
• Ability to work independently and stay highly organized.
• Fluent business English, written and spoken.

Requirements

• 4+ years in the pharmaceutical or clinical research industry.
• 2+ years in study start-up and ICF development.
• Experience drafting and managing ICFs at site, CRO, or sponsor level.
• Clinical background (e.g., RN) or familiarity with patient-facing documentation is a plus.
• Experience with Veeva is advantageous.

Education

• Bachelor’s Degree or international equivalent required; Life Sciences preferred.
• Advanced degrees (RN, Master’s, Doctorate) or relevant training, fellowships, or internships may be considered to supplement experience.

Travel Requirements

• Requires approximately 5-10% travel, including overnight and international travel to client sites.

Benefits

• Various annual leave entitlements.
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
• Life assurance.
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.