TMF Team Lead - EMEA/LATAM- Fixed term - Remote

Who we are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

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)

We love knowing that someone is going to have a better life because of the work we do. 

To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

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. 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.