Job Overview:

The Study Start-Up Specialist supports site start-up activities from potential site identification through site activation, ensuring timely delivery in compliance with applicable regulatory requirements and ICH/GCP guidelines. The role works closely with study teams, internal stakeholders, and site staff to coordinate start-up activities and support successful site activation.

Summary of Responsibilities:

• Coordinate site-level start-up activities from receipt of a potential site list through site activation.
• Collect and manage required site start-up and essential documentation, including CDAs and site questionnaires.
• Support IRB/EC and regulatory submission activities and preparation of study-level essential document templates.
• Manage ICF negotiations and facilitate escalation of issues where required.
• Prepare and submit IMP Release Packages and support other site activation requirements.
• Implement SSU strategies for the assigned region and collaborate with study teams, internal stakeholders, and site staff.
• Track and project site activation timelines, proactively identifying and escalating risks or delays.
• Maintain accurate and timely project status, financial information where applicable, and study information within relevant systems and tools.
• Support consistent implementation of global SSU processes, standards, and tools.
• Ensure all assigned activities are performed in compliance with applicable regulations, guidelines, and ICH/GCP requirements.

Qualifications (Minimum Required):

• BS/BA degree or Associate degree with at least 2 years of experience in healthcare or direct clinical trial-related experience.
• Knowledge of clinical trial conduct, drug development, and ICH/GCP guidelines.
• Strong project management and organizational skills with the ability to manage multiple activities and timelines.
• Excellent interpersonal, written, and verbal communication skills.
• Strong administrative and computer skills.
• Fluent in English.

Physical Demands/Work Environment:

• General Office Environment.
• Minimal travel required (0-5%)

Learn more about our EEO & Accommodations request here.