Start-up Specialist

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%)
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