Team Lead, TMF Operations - Mexico- Remote

What the Team Lead, TMF Operations does at Worldwide

The Team Lead, TMF Operations is responsible for maintaining Trial Master Files inspection readiness in compliance with the relevant Standard Operating Procedures, ALCOA principles, country regulations and industry best practice. The Team Lead will drive the delivery of Project Team objectives in ensuring the management of the essential documents. This is a global role and will require working with Worldwide Project Team members, Sponsors, 3rd Party Clinical Research Organizations and Quality Assurance.

What you will do

• Perform Records Management Compliance (RMC) Oversight Activities:
• Facilitate the delivery of TMF Services for 5-10 studies
• Monitor Key Performance Indicators and communicate performance to Project Teams (PT) and Sponsors
• Identify key risks and mitigate risks
• Analyze and interpret data to make informed data driven decisions
• Develop project specific Quality Management Documents (QMDs)

What you will bring to the role

• Analytical skills and critical thinking to evaluate and interpret complex situations/problems using multiple sources of information
• Display strong interpersonal skills in a fast-paced, deadline oriented, rapidly changing environment
• Ability to maintain direct reports, mentor, and train individuals
• Handle multiple, highly detailed tasks with exceptional accuracy, and ability to work under pressure
• Develops solutions to technical problems of moderate complexity
• Deliver advice to Project Team members on key TMF issues

Your experience

• University Degree preferred (Life Science desirable)
• Combination of education plus 3-5 years of relevant experience
• In depth knowledge of ICH GCP
• Experience in supporting GCP inspections (e.g., FDA, PMDA, EMA, Bfarm, MHRA, etc.)
• Experience of Document Management and/or eTMF solutions (e.g. Veeva, Trial Interactive, Documentum, etc.)
• Working knowledge of working within highly regulated industries (desirable)