Clinical Trial Assistant

The Global Clinical Trial Assistant MAO (GCTA MAO) assists with local project management activities of a clinical trial (s) (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. Reports to Sponsor Manager or designee, and partners with the Global Trial leader (GTL) to ensure overall study delivery at the country level.

What you will be doing

• Services rendered will adhere to applicable sponsor's SOPs, WIs, policies, local regulatory requirements, etc.

• 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 upto-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.

• If applicable, region-specific deliverables will be specified.

You Are

Bachelor’s degree or equivalent.
Degree in a health or science related field.
Excellent independent time management skills.
Experience in clinical research experience in the pharmaceutical industry or CRO.
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.
o Excellent decision-making skills and understanding of escalating appropriately
o Proficient communication skills (at all levels)
o Fluid thinker
o Experience in budgetary management

Benefits of Working in ICON:
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, 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.