Global Clinical Trial Support - Managed Access - Home Based

As a Global Clinical Trial Support you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Schedules study management team meetings for each project assigned and maintains documentation from meetings in appropriate repository.
• Assists in management of project budgets and Affiliate spend, reconciliation of invoices, final budget and liaises with Accounts payable, as necessary.
• Ensures study (s) compliance by maintaining and updating trial management systems, Clinical Trial Management System (CTMS), Trial Master File (eTMF) and Trial Master Source (TMS) ensuring up- to-date, complete and accurate status.
• Maintains internal project specific study sites to ensure availability of all central project documents.
• Liaises with external service providers (ESP) and contract research organizations (CRO) as needed.
• Continuous and up-to-date understanding of the study, processes and system/documentation requirements ensuring ongoing inspection readiness by complying with relevant training requirements.
• With focus on quality, supports on an ongoing basis the GTL, TM, GPL and Quality Assurance (QA)
  team with audit findings report and CAPA management.
• In complete partnership with the study team through the GTL, TM interactions, ensures timely document preparation and submission and approval tracking (and hence compliance with local regulatory requirements) for IEC/HA approvals, if applicable.
• Full utilization by timely and accurate time reporting.
• Demonstrates proactivity, active involvement, and independence in organizing and delivering work.
• Tracking and analyzing project budgets and Affiliate spend, reconciliation of invoices, final budget and liaises with Accounts payable, as necessary
• Actively drives and confirms compliance by maintaining and updating trial management systems, Clinical Trial Management System (CTMS), Trial Master File (eTMF) and Trial Master Source (TMS) ensuring up-to-date, complete and accurate status. Performs annual reviews, when required in system.
• Demonstrates the ability to proactively support, with focus on quality, GTL, TM, GPL and Quality Assurance (QA) team with audit findings report and CAPA management.
• Assist in Development of Master ICFs
  Guide provider G-CTAs in processes and management systems
• Assist in Development of complex study plans, (i.e. the Safety Monitoring Plan (SMP), External Service Provider (ESP) Oversight Plan, and Monitoring Guidelines)

You are:

• Bachelor’s degree. Degree in a health or science related field preffered
• Excellent independent time management skills.
• Experience in clinical research experience in the pharmaceutical industry or CRO.
• Experience with regulatory documents
• Literacy and proficiency in IT skills with appropriate software and company systems.
• 3 years relevant work experience; however, other relevant experiences and skills may be considered.
• Excellent decision-making skills and understanding of escalating appropriately
• Proficient communication skills (at all levels)
• Fluid thinker
• Experience in budgetary management
• 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

Why 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.

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.

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.

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.