Study Start Up Associate II

🔥 18 hours ago

🌲 North Carolina, Pennsylvania – Remote

🌲 North Carolina – Remote 🔔 Pennsylvania – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

👻 Ghost score 10%

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Support day-to-day SSU activities to meet established goals and objectives in compliance with GCP/ICH guidelines and regulatory requirements • Coordinate with study teams and business stakeholders to support timely completion of program goals • Generate accurate project status and financial information in tracking systems • Identify and escalate issues related to SSU deliverables • Execute assigned SSU activities and support global SSU standards • Oversee site-level start-up activities from potential site list receipt through site activation, including CDA and questionnaire collection, ICF negotiations, IRB/EC submissions, IMP Release and other activation requirements • Implement SSU strategy for the assigned region • Build relationships with internal counterparts and site staff • Project site activation timelines and escalate delays • Prepare study-level essential document templates and regulatory submission content • Handle ICF negotiations and escalations • Prepare and submit IMP Release Packages • Maintain accurate and timely information in clinical systems • Ensure regulatory and guideline compliance for assigned clinical trials • Provide guidance/oversight to contract staff as needed

🎯 Requirements

• BS/BA degree or Associates degree with ≥2 years of experience in clinical trial related start-up experience • ICF negotiation experience • Must have knowledge of clinical trial conduct • General knowledge of drug development and ICH/GCP guidelines • Requires proven project management skills • Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability • Fluent in English • Minimal (0-5%) travel required • Legal right to work in the country where the role is based

🏖️ Benefits

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways