The Global Clinical Trial Assistant MAO (GCTA MAO) assists with local project management activities of clinical trials or Medical Affairs data generation activities in one or more countries. Services include supporting operational aspects of assigned projects from start-up through closeout, depending on the therapeutic area and project-specific requirements. The role reports to the Sponsor Manager or designee and collaborates with the Global Trial Leader (GTL) to ensure successful study delivery at the country level.
Deliverables include:
1. Adherence to Sponsor SOPs, Work Instructions (WIs), policies, and local regulatory requirements.
2. Scheduling and documenting study management team meetings.
3. Managing project budgets, affiliate spend, invoice reconciliation, and liaising with Accounts Payable.
4. Maintaining and updating trial management systems such as CTMS, eTMF, and TMS to ensure accuracy and compliance.
5. Ensuring availability of all central study documents at internal sites.
6. Liaising with external service providers and CROs as needed.
7. Maintaining an up-to-date understanding of study processes and documentation to ensure inspection readiness.
8. Supporting audit and CAPA processes with focus on quality.
9. Coordinating document preparation and submission for IEC/HA approvals to ensure regulatory compliance.
10. Timely and accurate time reporting.
11. Demonstrating proactivity, independence, and active involvement in work organization and delivery.
12. Tracking and analyzing project budgets and spend, with reconciliation and liaising as necessary.
13. Supporting ongoing quality assurance activities and audit readiness.
14. Assisting in development of Master ICFs and complex study plans such as SMP, ESP Oversight Plan, and Monitoring Guidelines.
15. Creating study-specific newsletters as needed.
Education and experience requirements include:
* Bachelor’s degree or equivalent, preferably in a health or science-related field.
* Minimum of 3 years’ relevant experience in clinical research within the pharmaceutical industry or CRO.
* Proficiency in IT and company systems.
* Excellent decision-making, communication, and independent time management skills.
* Experience in budget management.
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence, dedicated to accelerating medical development and improving patient outcomes worldwide. Learn more at https://jobs.iqvia.com.
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