What The Team Lead, TMF Operations Does At Worldwide
La siguiente información tiene como objetivo proporcionar a los posibles candidatos una mejor comprensión de los requisitos para este puesto.

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 general role and will require working with Worldwide Project Team members, Sponsors, 3rd Party Clinical Research Organizations and Quality Assurance.

What You Will Do

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- 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

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- 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

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- 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)

Equal Opportunity

Worldwide 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. xhfqzwm 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.

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📌 Global Tmf Operations Lead (Madrid)
🏢 Worldwide Clinical Trials
📍 Madrid