TMF Analyst

Overview:

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.

Deliverables:

• Services rendered will adhere to applicable Johnson & Johnson 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 J&J 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.
• Develop, maintain and improve training courses/material for TMF processes and systems (e.g. SOPs, system manuals, client specific TMF Specifications, etc.)

Education and Experience Requirements:

• Undergraduate degree (or its international equivalent from an accredited institution). 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.
• 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.

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

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

The potential base pay range for this role, when annualized, is $57,000.00 - $95,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

Salary : $57,000 - $95,000