Local Clinical Trial Manager

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:

• Accountable for site-level goal setting and study-specific deliverables for clinical sites within their country(ies)
• Contribute to, deliver and/or lead CRA, Investigator and Study Coordinator training
• Oversight and monitoring of applicable vendor activities e.g., laboratories and equipment provisioning
• Communicate country status (including timelines and deliverables) to key stakeholders (e.g., GCMs, Program Managers, CST or TMT,
• Contribute and develop to program,/study-specific materials – e.g., monitoring plan, study specific training documents.
• Support and contribute to Clinical Study Teams (CSTs) / Trial Management Teams
• Planning, management, and oversight of clinical study execution in accordance with the global program strategy, through
• Maintain expert country, site and protocol knowledge to support sites with questions as well as build strong site relationships.
• Partner with global, local country teams and study team to provide high level country strategy, drive study progress and country level
• Maintain the quality and scientific integrity of clinical trials at a country level.
• Collaborate with cross functional internal and external stakeholders to ensure timely execution, budget execution of clinical trial.
• Primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up (COLA) to close out at a country level in accordance with ICH-GCP and other applicable local regulations deliverable within the country study delivery. (Accountable for study deliverables and drives key decisions within set country) leadership of the cross-functional Local Study Team (LST)
• Supports country-level operational planning and accountable for site selection within assigned country(ies) (TMTs) as applicable, agenda driven, present at meetings. DOM etc) with oversight as required and ensures updates to relevant systems
• Engage with local cluster team and local functions from a study perspective (e.g., Local Medical, DOM).
• Accountable for approval of Baseline and Revised Enrolment Plans (Country Level) assigned countries, management of ELE (enrolment long-range estimates)process
• Monitor the execution of the clinical study against timelines, deliverables, and budget for that country:
• Translate global start up requirements into local country targets
• Monitor country enrolment and retention and act on deviations from plan. Identify barriers to enrolment and support recruitmentand retention strategic solutions.
• Monitor and act upon data flow metrics - review, trend identification and analysis, with targeted follow up where appropriate
• Review Monitoring Visit Reports
• Contribute to the study-level forecast for investigational product, support study level accountability and reconciliation across

You are:

• A minimum of a BA/BS degree is required. 
• A degree in a health or science related field is preferred.
• Minimum two to four years  clinical trial management experience 
• Should have solid understanding of the drug development process including ICH/GCP and local regulatory requirements. 
• Solid communication and computer skills required. 
• Proficient in speaking and writing the country language and English language.  Good written and oral 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/benefitsICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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 or submit a request here.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.