Study Start Up Specialist

ICON plc

79d

About The Position

Study Start-up Specialist at ICON plc is a role focused on supporting the day-to-day operations of assigned activities within the Study Start-Up (SSU) team. The position involves ensuring compliance with GCP/ICH guidelines and other regulatory requirements while effectively communicating and coordinating with key business stakeholders to support timely completion of both drug and non-drug program goals. Responsibilities include generating project status updates, identifying and escalating issues, overseeing site-level SSU activities, and maintaining accurate information in clinical systems. The role requires a proactive approach to project management and relationship building with internal counterparts and site staff.

Requirements

• BS/BA degree or Associates degree with ≥2 years of experience in clinical trial related start-up experience.
• ICF negotiation experience.
• Knowledge of clinical trial conduct.
• General knowledge of drug development and ICH/GCP guidelines.
• Proven project management skills.
• Excellent interpersonal, written and verbal communication skills.
• Strong administrative skills and computer ability.
• Fluent in English.

Responsibilities

• Support the day-to-day operations of assigned activities within SSU.
• Ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines.
• Communicate and coordinate with key business stakeholders to support timely completion of program goals.
• Generate and provide accurate project status and financial information.
• Proactively identify and escalate issues related to SSU deliverables.
• Oversee site level SSU activities from receipt of a potential site list to site activation.
• Implement the SSU Strategy for assigned region during the study start-up period.
• Build relationships with internal counterparts and site staff.
• Project site activation timelines and escalate when necessary.
• Adhere to processes and tools designed to support the SSU team.
• Lead the preparation of study level essential document templates.
• Aid in the preparation of content for Regulatory submissions.
• Handle ICF negotiations and facilitate required escalations.
• Prepare and submit IMP Release Packages.
• Maintain accurate and timely information in relevant clinical systems.
• Comply with regulations and guidelines in support of assigned clinical trials.

Benefits

• Various annual leave entitlements.
• A range of health insurance offerings.
• Competitive retirement planning offerings.
• Global Employee Assistance Programme offering 24-hour access to support.
• Life assurance.
• Flexible country-specific optional benefits including childcare vouchers and discounted gym memberships.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees