10,000+ employees
Founded 1990
đź Consulting
đĽ Healthcare
đŚ 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.
đĽ 31 minutes ago
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10,000+ employees
Founded 1990
đź Consulting
đĽ Healthcare
đŚ 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.
⢠Accountable for delivery and quality of Phase I-IV, Epidemiology, Real World Evidence, Company Sponsored, Collaborative Research, Investigator Sponsored, Early Access, and other research activities ⢠Provide leadership, strategic direction, and operational oversight for Clinical Site Lead and/or Clinical Research Manager activities ⢠Serve as operational delivery expert and promote data-driven planning at site and study level ⢠Drive accountability and ownership among internal and external partners ⢠Identify and implement operational excellence strategies ⢠Identify trends, issues, and risks affecting study timelines, quality, and costs, and implement mitigation plans ⢠Drive risk-based site oversight, study management, and quality risk management ⢠Escalate trends, issues, and risks to appropriate teams and senior management ⢠Promote solution-oriented thinking and issue resolution at country, study, and program levels ⢠Support onboarding and enhance site/study management capabilities of new team members ⢠Promote product knowledge, collaboration, information sharing, and best-practice guidance ⢠Act as the operational link between Clinical Site Leads/Clinical Research Managers and global functions ⢠Lead regular calls and participate in investigator/study coordinator meetings ⢠Lead process improvement initiatives ⢠Use site performance and quality analytics to drive risk-based sponsor oversight ⢠Represent the Clinical Site Lead group at Clinical Operations/Trial Team meetings ⢠Assess country and site selection proposals and inform teams of decisions ⢠Design country start-up strategies and oversee site/country delivery ⢠Establish and update monitoring strategies based on identified risks and available data ⢠Develop, implement, and follow up on Site Oversight Plans ⢠Oversee sponsored and collaborative studies across setup, conduct, and delivery ⢠Act as global operations lead for Early Access activities and co-lead multifunctional teams with Medical Affairs ⢠Track progress, quality, milestones, and financial risks at program level ⢠Represent Clinical Trial Execution at governance boards ⢠Support program-level financial planning ⢠Provide functional leadership for Clinical Site Leads, Clinical Research Managers, Contract/FSP staff, and TCDLs as applicable ⢠Collaborate on resourcing and performance-related escalations ⢠Oversee external providers and drive innovation to reduce study timelines and costs
⢠Graduate background (Medical or Life Sciences degree) in a clinical research related discipline or equivalent ⢠Clinical operations experience, ideally across Phases I-IV ⢠Expert knowledge of clinical development principles, concepts, ICH GCP, and applicable regional/local regulations ⢠Oncology and/or Neurology and/or Immunology therapeutic area experience desired ⢠Substantial (10+ years) professional and project management experience in clinical research in a CRO, pharma or biotech company, including site management/oversight, clinical study planning and conduct ⢠Aptitude to interpret outputs from analytical tools to enhance and improve study execution ⢠Fluency in English (oral and written) plus local language ⢠Ability to work independently on assigned tasks or projects ⢠Ability to assess risk, solve problems and make decisions ⢠Ability to handle and oversee multiple tasks simultaneously and prioritize effectively ⢠Analytical skills, quick perception and good judgement ⢠Good interpersonal skills ⢠Good written and verbal communication skills ⢠Good presentation skills ⢠Good cultural awareness ⢠Legal right to work in the country where the role is based
⢠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 ⢠Domestic/international travel opportunity up to 20% of time
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