Clinical Operations Lead - Hematology/Von Willebrand Disease

Job title: Clinical Operations Lead - Hematology/Von Willebrand Disease

About the Role The Clinical Operations Lead supports the Clinical Trial Manager/operational team in the execution of trials and acts as a liaison with CROs and ancillary vendors to manage trial-related operational tasks. The role ensures clear communication with the project team and alignment with study timelines.

What You'll Do

• Review, develop and write clinical trial documents and manuals (e.g., study manuals, laboratory/biomarker plans) and maintain documentation quality.
• Create and maintain a Master Informed Consent Form (ICF) template and approve site changes with input from legal and safety when warranted; update templates for new risks and amendments.
• Help evaluate investigative sites; collaborate with Clinical Trial Logistics.
• Coordinate and monitor investigational-site activities; review monitoring trip reports and support the US monitoring organization.
• Develop and manage study timelines and priorities, including recruitment tools/strategies and patient retention plans.
• Plan and organize team meetings (investigator/coordinator meetings, DMC/SMC/safety calls).
• Assist in IP and co-medication strategy development (quantities, labels, depots, tracking) with other departments.
• Participate in data review and discrepancy resolution; coordinate with Pharmacovigilance/safety.
• Monitor study timelines and deliverables; manage external vendors (monitoring, sample management, IVRS, laboratory).
• Contribute to a multi-disciplinary trial team; build relationships with investigational sites; serve as a preliminary liaison to convey trial information and handle escalation pathways.
• Take on special projects to improve efficiency, effectiveness and quality of the Development Operations Department.

What We're Looking For

• BS/BA or relevant science degree.
• Minimum 5 years' clinical trial management experience in biopharma or related clinical research.
• Non-malignant hematology trial management experience, including Von Willebrand disease.
• Working knowledge of ICH Good Clinical Practices and regulatory/health authority experience.
• Ability to manage multiple priorities across several protocols/therapeutic areas.
• Prior multinational-trial experience is preferred.
• Must be legally authorized to work in the United States and not require visa sponsorship now or in the future.

Nice to Have

• Experience with Hematology/Von Willebrand disease trials (specific to role).
• IP and co-medication strategy development experience.
• Vendor management across CROs, monitoring, IVRS, laboratory, etc.

Compensation & Benefits

• Competitive salary and benefits package including health insurance, retirement planning, and life assurance.
• Various annual leave entitlements and flexible country-specific benefits (e.g., childcare vouchers, bike purchase schemes, gym discounts, subsidized travel passes, health assessments).
• Global Employee Assistance Programme with 24/7 access to support network.
• ICON is committed to an inclusive and accessible environment; accommodations are available upon request for applicants with disabilities during the application process or to perform the essential functions of a position.