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 client's 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 client's teams.
Requirements
- Bachelor's degree or 2–5 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 https://jobs.iqvia.com
