Overview
As a Global CTA you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Responsibilities
What you will be doing:
The Global Clinical Trial Assistant - Medical Affairs assists with local project management activities of a clinical trials or Medical Affairs data generation activity in a country or countries. Services/deliverables include assisting with operational aspects of assigned project(s) at the country level for end to end project management from start-up through to closeout activities. Further, services will range depending on the therapeutic area and project-specific requirements.
1. Schedules study management team meetings for each project assigned and maintains documentation from meetings.
2. Assists in management of project budgets and Affiliate spend, reconciliation of invoices, final budget and liaises with Accounts payable, as necessary.
3. Ensures study 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.
4. Maintains internal project specific study sites to ensure availability of all central project documents.
5. Liaises with external service providers (ESP) and contract research organizations (CRO) as needed.
6. Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements.
7. With focus on quality, supports GTL, TM, CPL and Quality Assurance (QA) team with audit findings report and CAPA management.
8. Keeps the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals, if applicable.
9. Full utilization by timely and accurate time reporting.
10. If applicable, region specific deliverables will be specified.
Qualifications
You are:
1. Bachelor's degree or equivalent experience
2. Degree in a health or science related field.
3. Excellent independent time management skills.
4. Experience in clinical research experience in the pharmaceutical industry or CRO
5. Literacy and proficiency in IT skills with appropriate software and company systems
6. Minimum of 2 years clinical experience highly preferred
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.
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