Team Lead, TMF Operations (EMEA/Remote)
Multiple Locations: Romania • United Kingdom • Serbia • Poland • Croatia
Requisition Number: 7323
Position Title: Team Lead, TMF Operations
Who we are
Worldwide Clinical Trials (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.
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
- 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
- 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.
Employment Type: Regular
Community / Marketing Title: Team Lead, TMF Operations (EMEA/Remote)
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.