ICON plc
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.
Study Start Up Associate – Medical Device
🔥 14 minutes ago
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ICON plc
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
• Through coordination with the Contract & Budget team, and collaboration with divisional and regional clinical teams, conduct clinical trial site start-up activities related to the preparation and approval of regulatory documents • Work independently and proactively to coordinate all necessary activities for site regulatory submissions and essential document collection for allocated clinical research sites • Manage multiple sets of essential regulatory documents across several studies and division portfolios • Partner with clinical sites to support the negotiation and customization of Informed Consent Form (ICF) • Develop and foster clinical research site relationships to become a subject matter expert in the site start up regulatory process across multiple studies • Leverage knowledge of site regulatory processes and division priorities to meet clinical study goals and objectives • Manage to achieve target IRB/EC timelines by assisting clinical research sites with the application submission process and approval tracking • Manage and problem solve site start up challenges that arise to mitigate impact to service level agreement and study goals • Update and maintain study-specific startup and close out trackers • Provide updates to leadership on site start up activities, investigator readiness, regulatory submission, approval status, etc. • Ensure compliance with appropriate regulatory requirements (ICH/GCP, MDR, GDPR, etc.) and internal SOPs/WI, policies & procedures.
🎯 Requirements
• Bachelor’s Degree, or an equivalent combination of experience and education • 3+ years’ experience in clinical/scientific research and medical device experience, specifically clinical study site start-up experience within the US • Medical device industry experience is preferred but not required • Relevant clinical research certifications (e.g., CCRP, SOCRA) may be considered in lieu of direct medical device experience • Experience performing the core roles and responsibilities of a Trial Operations CRA within the pharmaceutical, biotechnology, or related clinical research industries would be considered • Ability to multi-task: support several studies and/or personnel simultaneously, work in a very fast-paced environment • Ability to work in a team environment and possess clear, concise communication & presentation skills – written and verbal • Must be comfortable interacting with clinical research site personnel via phone and email.
🏖️ 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
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