TMF Operations Team Lead - Europe - Home-based

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 almost 2,500 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.

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. Identify, suggest, and support process improvements
• Attend and support re-qualification and study specific audits; organize the finding resolution and support Corrective Actions and Preventive Actions (CAPAs) process
• Support study calls in case of issues and escalations and provide escalation support to their teams. Oversee the Quality Check process and makes sure the RMC is on track

What you will bring to the role

• Applies 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
• Handle multiple, highly detailed tasks with exceptional accuracy, and ability to work under pressure
• Deliver advise to Project Team members on key TMF issues
• Able to escalate issues and offer solutions for resolution via process improvement suggestions
• Demonstrate strong planning and organizational skills

Your experience

• University Degree preferred (Life Science desirable)
• Combination of education plus 3-5 years of relevant experience
• 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.)

Why Worldwide

At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it - because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.

Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers!

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