As a (Project Manager) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Participates in clinical trial scenario planning (estimates timeline and cost, request internal resource)
• Works with Strategic resourcing team to select study vendors
• Oversees study vendors to ensure quality and delivery
• Oversees the development of and adherence to clinical trial project timelines
• Ensures senior Clinical Operation staff, DCT, and line function heads are informed of and understand risks / challenges, which includes putting risk mitigation plans in place, monitoring risk metrics, and communicating those risks
• Coordinates the relevant and timely exchange of information / materials (e.g., subject enrollment, site selection/feasibility, and data collection) with other Company functions (primarily those represented on CST) to support clinical trials delivery within the drug development process
• Ensures study plans (including but not limited to project plan, communication plan, issue escalation plan, clinical monitoring plan, medical monitoring plan, drug safety monitoring plan, data monitoring plan, Trial Master File plan and etc) are created, updated and distributed timely
• Coordinates with Clinical Supply Chain regarding drug forecasting and supply of drug products to sites
• Ensures site monitoring reports are accurate and reviewed on a regular basis
• Closely monitors Case Report Form (CRF) data entry and source document verification (SDV) status
• Ensures that Trial Master File (TMF) for assigned clinical trial(s) is created, maintained, QC checked and complete on a timely basis
• Adheres to and contributes to the development and review of Clinical Operations Work Instructions and SOPs, if require
• Conducts Study Oversight Visit (SOV), if required
• Ensures inspection readiness at any point in time throughout the study life cycle
• Prepares team for quality assurance audits and inspections

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You are:

• Fluent in English
• Excellent organizational skills and ability to prioritize and multi-task
• 8 years or above of progressive experience in clinical research within the biotech, pharmaceutical sector, CRO industry or relevant field
• Documented training, knowledge and application of current FDA Regulations, GCP and
• ICH guidelines in clinical trials required
• Management experience of CROs and other Vendors preferred
• Therapeutic or medical knowledge preferred
• Experience developing trial plans including project plan, site monitoring, pharmacy and lab manuals, risk mitigation strategies, trial budgets and site selection/feasibility
• Exhibits a strong understanding of methodologies and approaches
• Strong written and verbal communication skills

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• 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

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.