Clinical Research Manager - Oncology - Home Based (US)

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

What you will be doing:

• Main POC for assigned protocols and link between Country Operations (CO) and clinical trial team (CTT).
• Project management of assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
• Accountable for performance of assigned protocols in country in compliance with ICH/GCP, country regulations, client policies and procedures, quality standards and adverse event reporting requirements internally and externally.
  • Reviews Monitoring Visit Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management
  • Performs Quality Control visits as required
• Leads local study teams in high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert & coordinates activities across different local country roles.
• Creates and executes local risk management plans
• Supports compliance with CTMS, eTMF and other systems
• Escalates issues to TA Director/CRD/CQM/CTT
• Collaborates with functional outsourcing vendors, investigators and other external partners in studies
• Country POC for programmatically outsourced trials for assigned protocols
• Serves local business needs in his/her country (if delegated, signs contracts and manages budgets)
• Collaborates internally with HQ functions and local with PV, Regulatory and GMA to align on key decisions
• Builds business relationships and represents the client with investigators
• Shares protocol-specific information and best practices across countries/clusters

What you need to have

• Bachelor’s degree in science or similar required. Masters, PhD, MD (preferred)
• At least 5 years experience in clinical research (required)
• Previous CRA experience (preferred)
• Oncology experience (Required); Oncology Early Development experience (preferred)
• Ability to travel up to 30%
• Clinical trial management experience (required) 
• Project/Site Management knowledge
• Demonstrated success of strong organizational skills
• Strong understanding of local regulatory environment
• Strong scientific and clinical research knowledge
• Strong understanding of clinical trial planning, management and metrics
• Ability to focus on multiple deliverables and protocols simultaneously
• To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status

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/benefitsAt 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-accommodationsInterested 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.