Global Trial Manager - Clinical Document Specialist - Novartis: homebased

Global Trial Manager - Clinical Document Specialist - Novartis dedicated

Supports operational and some scientific aspects of global clinical trial(s), under the management of the (Associate) Global Trial Director. Core member of the Clinical Trial Team.

Responsibilities:

Supports the (Associate) Global Trial Director to ensure all trial deliverables are met according to timelines, budget, operational procedures, quality /compliance and performance standards. Assigned responsibilities can include but are not limited to:

• Trial Master File QC activities- reviewing availability of documents, key document checks, creating checklists, pulling reports etc
• Tracking and updating 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:

• Advanced degree or equivalent education/degree in life science/healthcare recommended.
• 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
• Fluent English (oral and written).
• Good communication, organization and tracking skills.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.