DirecciónWho we are
Worldwide, a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality.Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.
Our talented team of 3,000+ professionals spans 60+ countries.We are united in cause with our customers to improve the lives of patients through new and innovative therapies.
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 LeadTMF 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
- Develop project specific Quality Management Documents (QMDs)
- 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
- Be responsible for TMF Processes documentation and Records Management Compliance related items filing in TMF and/or Study SharePoint
What you will bring to the role
- Ability to apply analytical skills and critical thinking to evaluate and interpret complex situations/problems using multiple sources of information
- Ability to maintain direct reports, mentor, and train individuals
- Ability to escalate issues and offer solutions for resolution via process improvement suggestions
- Strong planning and organizational skills
- Demonstrated proficiency in Microsoft Word and Excel
- Proficient understanding of clinical research principles and processes
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)
Why Worldwide
We love knowing that someone is going to have a better life because of the work we do.
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