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.
Deliverables:
• Services rendered will adhere to applicable SponsorSOPs, 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.
• 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)
• Create study specific newsletters, as needed
Education and experience requirements
• 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
• Proficient communication skills (at all levels)
• Fluid thinker
• Experience in budgetary managemen
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