Local Trial Manager Ireland

Local Trial Manager homebased in Ireland

In this role, you will lead, manage and co-ordinate the conduct of clinical trials from study start-up to close out at a country level in accordance with ICH-GCP and applicable local regulations, by keeping quality and scientific integrity of clinical trials at a country level.  In addition, as a Local Trial Manager you will collaborate with cross-functional stakeholders to ensure timely and on budget execution of clinical trial deliverables within the country. You will be a local/country expert with identifiable project management experience locally.

Key responsibilities include;

• Planning, management and oversight of clinical study execution
• Accountable for study deliverables in that country
• Leads country-level operational planning and supports site selection
• Ensure key stakeholders are kept informed of study progress e.g. global leads, global clinical project managers, etc. and provides country level input
• Ensure effective study risk management
• Contribute to development of study-specific materials – e.g. monitoring plan, study specific training documents.
• Contribute to, deliver and/or lead staff training
• Oversight and monitoring of applicable vendor activities
• Identifying risk, implementing risk mitigation strategies and resolving issues at a country/site level and leading and continually reviewing country level risk mitigation activities to ensure study delivery to plan
• Contributes to the study-level forecast for investigational product, support study level accountability and reconciliation across assigned countries, management of ELE (enrolment long-range estimates) process.
• Monitors the execution of the clinical study against timelines, deliverables, and budget for that country.
• Monitors country enrolment and retention, and act on deviations from pl Identify barriers to enrolment and support recruitment and retention strategic solutions.
• ReviewsMonitoring Visit Reports.
• Provides updates regarding the study budget and obtains approval for budget deviations for clinical sites (outside of range).
• Supports internal audit and inspection activities and contributes to CAPAs, including leading resolution of issues when appropriate g., vendor management.
• Participates in cross-functional task forces/process improvement groups

You will need:

• Ideally BA/BS/BSc preferred
• Ideally at least 3 years’ clinical trial project management experience/ leading local/regional or global teams gained in Ireland
• Ideally solid work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
• Experience in oversight of external vendors (e.g. CROs, central labs, imaging vendors, etc.)

What is offered

• The opportunity to work with a sought-after company
• Structured training and on-boarding
• Permanent and full-time contract of employment with us 100% seconded to one sponsor
• Flexibility to work fully home-based
• An attractive salary package

Why Join?

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs.  In addition, our best-in-class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, 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.

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