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- Tasks: Assist in managing clinical trial activities from start to finish, ensuring compliance and quality.
- Company: Join IQVIA, a global leader in clinical research and healthcare intelligence.
- Benefits: Enjoy flexible work options, professional development opportunities, and a collaborative culture.
- Why this job: Make a real impact on patient outcomes while gaining valuable experience in the healthcare industry.
- Qualifications: Bachelor’s degree in health or science, with 3 years of relevant experience preferred.
- Other info: Proficiency in IT and budget management is essential; strong communication skills are a must.
The predicted salary is between 36000 - 60000 £ per year.
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
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
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Global Trial Assistant - Sponsor Dedicated employer: IQVIA
Contact Detail:
IQVIA Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Global Trial Assistant - Sponsor Dedicated
✨Tip Number 1
Familiarise yourself with the specific clinical trial management systems (CTMS) mentioned in the job description. Understanding how these systems work will not only help you during the interview but also demonstrate your proactive approach to learning.
✨Tip Number 2
Network with professionals already working in clinical research or as Global Trial Assistants. Engaging with them on platforms like LinkedIn can provide you with insider knowledge about the role and the company culture at StudySmarter.
✨Tip Number 3
Stay updated on the latest trends and regulations in clinical trials, especially those relevant to the therapeutic areas you might be working in. This knowledge can set you apart during discussions with the hiring team.
✨Tip Number 4
Prepare to discuss your experience with budget management and project tracking. Be ready to share specific examples of how you've successfully managed budgets or timelines in previous roles, as this is a key aspect of the position.
We think you need these skills to ace Global Trial Assistant - Sponsor Dedicated
Some tips for your application 🫡
Tailor Your CV: Make sure to customise your CV to highlight relevant experience in clinical research and project management. Emphasise any specific skills that align with the job description, such as budget management and compliance with regulatory requirements.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for clinical trials and your understanding of the role. Mention specific experiences that demonstrate your ability to manage projects and liaise with various stakeholders effectively.
Highlight Relevant Experience: In your application, clearly outline your previous roles in clinical research or related fields. Include details about your responsibilities and achievements, particularly those that relate to the tasks mentioned in the job description.
Showcase Communication Skills: Since the role requires proficient communication skills, provide examples of how you've successfully communicated with teams or external partners in past positions. This could be through managing meetings, preparing reports, or liaising with service providers.
How to prepare for a job interview at IQVIA
✨Understand the Role Thoroughly
Before the interview, make sure to read the job description carefully. Familiarise yourself with the responsibilities of a Global Trial Assistant and be prepared to discuss how your skills and experiences align with these tasks.
✨Showcase Your Project Management Skills
Since the role involves managing various aspects of clinical trials, be ready to provide examples of your project management experience. Highlight any specific tools or methodologies you’ve used in previous roles that relate to trial management.
✨Demonstrate Compliance Knowledge
The position requires adherence to regulatory requirements and internal policies. Be prepared to discuss your understanding of compliance in clinical research and any relevant experiences you have had ensuring adherence to such standards.
✨Prepare Questions for the Interviewers
Having insightful questions ready shows your interest in the role and the company. Ask about the team dynamics, the types of projects you would be working on, or how success is measured in this position.