ICF Manager

ICON plc • Blue Bell, SD

6d • Onsite

About The Position

ICF Manager ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. 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.

Nice To Haves

• Clinical background (e.g., RN) or familiarity with patient-facing documentation is a plus.
• Experience with Veeva is advantageous.

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

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

What This Job Offers

• Job Type: Full-time
• Career Level: Manager