Document Manager, Submission Readiness - Sponsor Dedicated (home-based UK, Poland, Bulgaria)

Full Job Description

Job Purpose

Main duties

• Ensure efficient and appropriate management of submission-relevant documentation ((e.g., Protocol, CSR, ICF, PDR, etc.) for global clinical, preclinical/bioanalytical) to meet electronic publishing requirements, HA guidelines, Good Clinical Practices and internal SOPs.
• Support implementation of the submission document readiness management strategy for clinical documents and clinical documents templates
• Develop and maintain submission readiness processes, contribute to or drive initiatives to improve and innovate business and technical aspects of submission readiness activities, in collaboration with other CDGM groups, business and IT Functions.
• Collaborate with cross-functional stakeholders (e.g., Regulatory Writing & Submissions, Regulatory Affairs, Trial Management, etc.) on the planning, preparation and delivery of high quality documents within timelines.
• Support internal customers with issue resolution and management of expedited urgent requests
• Assist with oversight of vendors delivering services to submission readiness team, including developing and recommending risk management, contingency plans and corrective or preventative actions to improve quality and compliance
• Support CDGM and business teams in preparation for and during audits, inspections and migration activities

Key Performance Indicators

• Timely submission, delivery of high quality TMF documentation enabling regulatory compliance and applications for marketing approval.
• External satisfaction, acceptability of clinical documentation by Health Authorities.
• Efficient use of resources through operational effectiveness of document management and archiving
• External reputation of Sponsor clinical documentation, with Health Authorities 

Ideal Background (education/experience)

• Thorough knowledge of clinical document management processes
• Advanced knowledge of clinical documentation best practice guidelines & principles (good documentation practice, data integrity)
• 3-5 years in clinical development/clinical operations or similar business area
• 3 years working experience with document management systems and excellent understanding of system structures and generic document management functionality
• Good understanding of technical processes and PC environment including Microsoft suite of products
• Advanced ability to work independently
• Experience with project work or project management in a global, cross-functional multicultural and international matrix organization
• Excellent communication, organization and tracking skills

#LI-remote

#LI-MARIAGALLUZZO

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at