Manager Implementation Services - Reading, Berkshire, United Kingdom - IQVIA Argentina

Description

Responsible for efficient and appropriate management of Trial Master Files (TMF) and other TMF related, inspection relevant documents from creation through archival in compliance with applicable SOPs, processes and study specific requirements for assigned trials according to established timelines.

Drive TMF Quality at trial level:
Provide subject matter expertise, ensures compliance with TMF processes and tools and promotes awareness of the importance of a high quality TMF
Support the definition and refinement of the document management strategy for TMFs within each assigned Clinical Trial Team (CTT)
Responsible for TMF Quality & completeness review:
Review TMF quality early and during the study, with targeted and risk based approach
Identify & communicate gaps completeness and quality gaps throughout the study
Understand specific study risks and how they translate into TMF risks (e.g. Issue on data integrity)
Identify and communicates trends/risks based on review at project level, and aligns across projects for consistency
Oversee the process, system and tool landscape that supports the management of TMFs
Responsible for definition of applicability and number of expected documents in the eTMF systems, and TMF management plan (if applicable)
Provide input on queries from Technical QC, and seeks LF input


Key Performance Indicators:
Timely and high-quality provision of new or updated document management standards and guidance documents
Smooth and timely implementation of a new DMS production environment addressing business benefits
Thorough knowledge of clinical Trial Master File process/activities, regulatory requirements and Good Clinical Practice
Knowledge of applicable research and regulatory environments, i.e. Good understanding of technical processes and PC environment including Microsoft suite of products
Knowledge of the national and international data protection legislation
Experience with project work or project management in a global, cross-functional multicultural and international matrix organization
Ability to handle multiple tasks and projects within defined timelines and balance competing priorities
Minimum 6 years of experience with document management systems and excellent understanding of system structures and generic document management functionality
Bachelor's degree in life science/healthcare is required; Fluent written and oral English

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.