TMF Analyst

The 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.

Responsabilities:

• Services rendered will adhere to applicable Sponsor SOPs, Wls, 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 Sponsor teams
• Manage global projects and initiatives, including corporate strategies, CAPAs, etc.
• Identify TMF process and training gaps throughout the organization; strategize and lead implementation of solutions.
• Collect, review, communicate and correct quality data through data analytics tools and processes Identify TMF solutions and standards for key clients.
• Participate in analysis, development, testing and implementation of TMF and Document Management technology, including external systems and solutions
  
  

Requirements

• 2-5 years in the industry working in a TMF related area in replacement of education.
• Demonstrated application of processes, systems and maintenance of the paper and electronic Trial Master File.
• Read, write and speak English, fluent in host country language.
• Proficient working within a Microsoft Office Environment Prior industry experience in a TMF- related field,
• CTMS and eTMF systems experience. Veeva experience is recomended
• Experience with problem solving/solution implementations.
• Prior experience in a leadership role.
• Prior experience leading TMF related functions or projects Experience with change management, training and process improvement techniques.
• Knowledge of ICH/GCP, local regulatory authority and clinical development regulations
• Demonstrates excellent organizational and multi-tasking skills.
• Demonstrates thorough follow-up and follow-thru to problem resolution, timelines and deliverables.
• Demonstrates leadership and delegates appropriately.
• Advanced understanding of processes, systems and maintenance of the paper and electronic Trial Master File.
• Knowledge of change management, training and process improvement methodologies.
• Knowledge of System Development Lifecycles.
• Certification in Project Management, Six Sigma or LEAN.
• Coursework in business issues and management (e.g. operational analysis, organization behavior, budgets, etc.), required for experienced candidates.
• Please note This role is not eligible for UK visa sponsorship
  
  

Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered.

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