Study Start-Up Associate II

🔥 20 hours ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

✨ Associate

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

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

• Lead the initiation of clinical trials, ensuring compliance with regulatory requirements • Contribute to site start-up and activation activities • Work directly with assigned sites on all site related essential document collection and review • Assist with Country level ICD preparation • Review and approve site level ICDs • Partner with internal Study Startup team, CROs, Clinical Operations teams, and TAU partners to improve overall SSU metrics and deliver processes • Ensure standards are applied to the SSU processes across projects • Review site essential documents for start-up including but not limited to: ICF, FDF, 1572, CVs etc • Promptly recognize and improve potential site activation delays and escalate to appropriate team members • Track all actions and communications with sites to ensure timelines are achieved for studies and sites assigned • Support resolving escalated issues identified by the CROs and Clinical Operations teams in partnership with the internal Study Startup team • Review and provide feedback to management on site performance metrics • Ensure accuracy and completeness of the eTMF for assigned sites during start up

🎯 Requirements

• BS degree or international equivalent • 2 or more years of experience in clinical research Site Start Up within a pharmaceutical company, CRO or relevant industry vendor • Ability to explain data to facilitate decision making processes to be data driven • Knowledge and understanding of clinical study protocols and essential documents • Strong organizational skills, decision making, communication and negotiation skills • Proficient in Microsoft Excel, Word, and PowerPoint

🏖️ 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