Team Lead, TMF Operations - Europe - Home-based
Multiple Locations: United Kingdom • Poland • Bulgaria • Croatia • Romania
Requisition Number: 5252
Position Title: Team Lead, TMF Operations
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
- Serve as subject matter expert on Records Management Compliance processes
- Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices
- Work with a variety of Electronic Document Management and electronic TMF Systems to review, classify and process Essential Documents
- Provide leadership in promoting TMF Compliance and continual Inspection readiness
What you will bring to the role
- Able to escalate issues and offer solutions for resolution via process improvement suggestions
- Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information
- Display strong interpersonal skills in a fast-paced, deadline oriented, rapidly changing
- Handle multiple, highly detailed tasks with exceptional accuracy
- Develops solutions to technical problems of moderate complexity
- Deliver advise to Project Team members on key TMF issues
- 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)
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!
Employment Type: Regular
Community / Marketing Title: Team Lead, TMF Operations - Europe - Home-based
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.