Back to search
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.
Key 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.
Key Skills and Competencies
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.
Experience
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.
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- 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
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply
Learn more about this Employer on their Career Site
