ph3What The Team Lead, TMF Operations Does At Worldwide /h3 pThe 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 integral role and will require working with Worldwide Project Team members, Sponsors, 3rd Party Clinical Research Organizations and Quality Assurance. /p h3What You Will Do /h3 ul liPerform Records Management Compliance (RMC) Oversight Activities /li liFacilitate the delivery of TMF Services for 5-10 studies /li liMonitor Key Performance Indicators and communicate performance to Project Teams (PT) and Sponsors /li liIdentify key risks and mitigate risks /li liAnalyze and interpret data to make informed data driven decisions /li liDevelop project specific Quality Management Documents (QMDs) /li /ul h3What You Will Bring To The Role /h3 ul liAnalytical skills and critical thinking to evaluate and interpret complex situations/problems using multiple sources of information /li liDisplay strong interpersonal skills in a fast-paced, deadline oriented, rapidly changing environment /liliAbility to maintain direct reports, mentor, and train individuals /li liHandle multiple, highly detailed tasks with exceptional accuracy,



and ability to work under pressure /li liDevelops solutions to technical problems of moderate complexity /li liDeliver advice to Project Team members on key TMF issues /li /ul h3Your Experience /h3 ul liUniversity Degree preferred (Life Science desirable) /li liCombination of education plus 3-5 years of relevant experience /li liIn depth knowledge of ICH GCP /li liExperience in supporting GCP inspections (e.g., FDA, PMDA, EMA, Bfarm, MHRA, etc.) /li liExperience of Document Management and/or eTMF solutions (e.g. Veeva, Trial Interactive, Documentum, etc.) /li liWorking knowledge of working within highly regulated industries (desirable) /li /ul h3Equal Opportunity /h3 pWorldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. /p /p #J-18808-Ljbffr

📌 Team Lead, TMF Operations - Argentina- Remote (Madrid)
🏢 Worldwide Clinical Trials
📍 Madrid