Clinical Files Specialist
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Skills
About the role
Join our dynamic team as a Clinical Files Specialist (CFS).
Job Overview: As a Clinical Files Specialist, 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:
- Assist CRAs & RSU teams in updating and maintaining clinical documents and systems, ensuring site compliance and performance within project timelines.
- Work with the clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports.
- Conduct periodic reviews of study files to ensure completeness and accuracy.
- Act as a central contact for the clinical team, managing project communications, correspondence, and documentation.
Qualifications:
- Bachelor's degree in a Healthcare field.
- Effective written and verbal communication skills in Arabic, including a fluent 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 good documentation requirements & practices.
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 Cairo, Egypt.
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
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.