Clinical Document Specialist- Sponsor dedicated

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

Clinical Document Specialist- sponsor dedicated

Responsibilities-

• Trial Master File QC activities- reviewing availability of documents, key document checks, creating checklists, pulling reports etc
• Track and update clinical documentation tasks as per QC activities
• Maintenance of team portal/trackers as appropriate (e.g., correct content and links)
• Supporting initial TMF inventory check, QC, gap analysis for ongoing transitioned studies other companies to Novartis
• Any other document support identified during the QC like importing documents at HQ level, supporting correct mapping etc
• Collaboration and follow up with multiple stakeholders as appropriate and needed

Background-

• Understanding of the overall clinical drug development process and Good Clinical Practice
• Working knowledge of Trial Master File (TMF) and various types of clinical documents like TMF table of content, CSR etc
• Experience in working with clinical documentation systems
• Adequate MS Word, MS Excel, power point skills are required
• Well-organized, detail-oriented and excellent follow-up skills
• Good oral and written communication skills are required

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.