ICF Manager

ICON plc • Blue Bell, SD

1d

About The Position

ICF Manager ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development 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.

Requirements

• 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.
• 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.
• Bachelor’s Degree or international equivalent required; Life Sciences preferred.

Nice To Haves

• Clinical background (e.g., RN) or familiarity with patient-facing documentation is a plus.
• Experience with Veeva is advantageous.
• Advanced degrees (RN, Master’s, Doctorate) or relevant training, fellowships, or internships may be considered to supplement experience.

Responsibilities

• 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.

Benefits

• In addition to your competitive salary, ICON offers a range of additional benefits.
• Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
• Our benefits examples include: 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees