Location: Mexico.
Home-based role.
Job Overview
The Sr TMF Analyst or TMF Solutions Management is responsible for providing oversight to assigned aspects of TMF systems processes and learning strategies.
Supporting the TMF Process Owner and IT the TMF Solutions Management works with subject matter experts and leaders across all departments to ensure user needs are met and TMF strategies are consistent with the needs of the business our clients and regulatory expectations.
The TMF Solutions Management is the liaison between operations and Corporate Services (e.g. IT Process and Learning Management etc.). Assignments may include new process initiatives client requirements system configuration and validation vendor management CAPA representation as well as maintenance and ongoing oversight of existing practices.
Services rendered will adhere to applicable clients SOPs WIs policies local regulatory requirements etc.
Participate in analysis development testing and implementation of TMF and Document Management technology including external systems and solutions.
Develop maintain and improve process and training courses/material for TMF strategies (e.g. SOPs system manuals client specific TMF Specifications etc.).
Lead assigned solutions for target area.
Identify TMF solutions and standards for clients teams.
Requirements
Bachelors degree or 25 years in the industry working in a TMF related area in replacement of education.
Prior industry experience in a TMF-related field.
Back end administration experience with Veeva TMF or similar system.
Demonstrated application of processes systems and maintenance of the paper and electronic Trial Master File.
Knowledge of ICH/GCP local regulatory authority and clinical development regulations.
Read write and speak English fluently.
Proficient working within a Microsoft Office Environment.
Experience with problem solving/solution implementations.
Knowledge of change management training and process improvement methodologies.
Demonstrates excellent organizational and multi-tasking skills.
Demonstrates thorough follow-up and follow-thru to problem resolution timelines and deliverables.
Experience with bots automations data migrations would be highly valued
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
Required Experience:
Senior IC
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more