ICON plc is a leading global provider of outsourced development and commercialization services to the pharmaceutical, biotechnology, and medical device industries. They specialize in a full range of services, including clinical trial management, regulatory affairs, and patient recruitment, aiming to advance the development of transformative therapies across various sectors. ICON employs innovative technology and data solutions to streamline the drug development process and ensure effective clinical outcomes for patients.
Medical Device • Therapeutics • Government and Public Health Solutions • Clinical Research Services • Commercialisation and Outcomes
April 15
ICON plc is a leading global provider of outsourced development and commercialization services to the pharmaceutical, biotechnology, and medical device industries. They specialize in a full range of services, including clinical trial management, regulatory affairs, and patient recruitment, aiming to advance the development of transformative therapies across various sectors. ICON employs innovative technology and data solutions to streamline the drug development process and ensure effective clinical outcomes for patients.
Medical Device • Therapeutics • Government and Public Health Solutions • Clinical Research Services • Commercialisation and Outcomes
• Joining a well-established yet expanding team fully outsourced to one of our global pharmaceutical clients, the Clinical Trial Manager ensures overall successful execution of phase 1-4 clinical trials in multiple therapeutic areas, in accordance with applicable Standard Operating Procedures, agreed timelines, budgetary and regulatory requirements, at a global scale • The Clinical Trial Manager serves as the leader for the Study Management Team, with ultimate responsibility for the set-up, planning and coordination of clinical trials through to study closure • Managing and tracking key study metrics to ensure adherence to project milestones, along with communicating with other departments, will form a key part of this role • Reporting to a Clinical Program Leader, you will ensure accurate budget management, including guaranteeing that third-party vendors are working to defined plans • Other fundamental tasks include driving activity to ensure that enrolment commitments are met, whilst also checking that relevant documentation is duly updated, resolving problems, proactively managing risk and (where necessary) timely escalating issues • Clearly, the Clinical Trial Manager will also work in accordance with applicable health authority regulations and internal standard operating procedures • Where necessary, participation in the preparation for and conduct of Health Authority inspections and internal audits will also feature in this role • Working at the very heart of the clinical trial, you will deliver appropriate training to your study team on a trial-specific basis • Additionally, you will act as a key liaison with Quality Management in order to establish a high level of quality throughout the project lifecycle
• BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, and Pharmacy) • Previous experience of working with multiple therapeutic areas, including oncology, cardiology/metabolism, infectious disease, immunology and/or vaccines is preferred • 6 - 8 years clinical trial management/trial oversight experience in the pharmaceutical industry or CRO • Proven track record in successfully managing various aspects of trials from Start-Up to Database Lock and Trial Closure (End to End study experience) • Experience and ability in coordinating global or regional teams in a virtual environment • Proven ability to foster team productivity and cohesiveness • Experience and ability in coordinating global teams in a virtual environment for a minimum of 3 years • Willing to travel up to 20%
• Various annual leave entitlements • A range of health insurance offerings to suit you and your family’s needs • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being • Life assurance • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
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