Local Trial Manager

Roles & Responsibilities
• Lead and manage end-to-end local clinical trial activities in alignment with study protocol, ICH-GCP, and company SOPs
• Oversee site feasibility, selection, study start-up, monitoring oversight, and close-out activities
• Ensure timely regulatory submissions, ethics approvals, and site activation
• Act as the primary local point of contact for investigators, site staff, vendors, and global study teams
• Drive study timelines, enrollment targets, and milestone delivery while proactively managing risks and issue resolution
• Monitor site performance metrics and implement corrective and preventive actions (CAPA) when required
• Provide oversight and guidance to CRAs to ensure high-quality monitoring and compliance
• Ensure inspection-readiness through robust TMF review, documentation oversight, and compliance tracking
• Support sponsor audits, internal audits, and regulatory inspections
• Track and report study progress, risks, and key performance indicators (KPIs) to stakeholders
• Manage vendor deliverables and ensure contractual and operational compliance
• Maintain effective cross-functional collaboration with regulatory, data management, safety, and medical teams
• Ensure adherence to quality standards and drive continuous process improvement

Qualification
• Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or related field
• Advanced certification in Clinical Research or Project Management (preferred)
• Bachelor of Pharmacy, Master of Pharmacy

Experience
• 12+ years of experience in Clinical Operations with strong onsite monitoring background
• 2–3 years of project management or study leadership experience
• Proven experience in Oncology, Cardiology, or Pulmonology clinical trials
• Experience managing multi-site, complex global studies

Skills
• Strong knowledge of ICH-GCP, regulatory requirements, and clinical trial processes
• Demonstrated leadership and stakeholder management capabilities
• Strong risk management and problem-solving skills
• Ability to manage high-pressure timelines and complex deliverables
• Excellent communication and negotiation skills
• Strong organizational and documentation oversight skills
• Proficiency in CTMS and clinical trial systems
• High attention to quality, compliance, and inspection readiness

About the Organization
ICON plc is a global healthcare intelligence and clinical research organization supporting pharmaceutical, biotechnology, and medical device companies in clinical development. ICON is committed to operational excellence, innovation, and building a diverse culture that rewards high performance while promoting well-being and work-life balance.