Job Title: Senior Clinical Trials Assistant (CTA), Sponsor Dedicated
Location: São Paulo, Brazil (Hybrid Work Modality)
Join our dynamic team as a Senior Clinical Trials Assistant (CTA) for one of our sponsor partnerships.
Job Overview: As a Senior CTA, you will play a pivotal role in ensuring the accuracy and completeness of the Trial Master File (TMF) delivery. Collaborating closely with Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) teams, you will drive change management initiatives, revising current processes and suggesting improvements to enhance efficiency and compliance.
Key Responsibilities:
Change Management: Lead and participate in the revision of current processes, suggesting and implementing improvements to drive efficiency and compliance.
Document Management: Assist CRAs and RSU teams in updating and maintaining clinical documents and systems, ensuring site compliance and performance within project timelines.
Collaboration: Work with the clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports.
Quality Assurance: Conduct periodic reviews of study files to ensure completeness and accuracy.
Supply Coordination: Collaborate on the preparation, handling, and distribution of Clinical Trial Supplies, maintaining tracking information.
Data Management: Coordinate the tracking and management of Case Report Forms (CRFs), queries, and clinical data flow.
Communication: Act as a central contact for the clinical team, managing project communications, correspondence, and documentation.
Mentorship: Mentor less experienced CTAs, assisting with training and onboarding.
Leadership: Lead CTA study teams and participate in departmental quality or process improvement initiatives.
Site Visits: Accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.
Qualifications:
Bachelor's degree in a Healthcare field.
Minimum of 5 years of administrative support experience.
Minimum of 2 years of clinical research experience strongly preferred (equivalent combination of education, training, and experience).
Effective written and verbal communication skills, including a good command of the English language.
Proficiency in Microsoft Word, Excel, and PowerPoint.
Strong time management and organizational skills.
Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
Knowledge of applicable clinical research regulatory requirements (GCP and ICH guidelines).
Knowledge of applicable protocol requirements as provided in company training.
Why Join Us?
Innovative Environment: Be part of a team that values innovation and continuous improvement.
Professional Growth: Opportunities for mentorship, leadership, and professional development.
Impactful Work: Contribute to meaningful change management initiatives.
Flexible Work Modality: Enjoy a hybrid work environment based in São Paulo, Brazil.
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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What We Do
IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 70,000 employees, IQVIA conducts operations in more than 100 countries. To learn more, visit www.iqvia.com.
