Senior Associate I, TMF Operations - UK - 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.

Why Worldwide
We are Worldwide Clinical Trials, a global team of over 3,500+ experts, bright thinkers, dreamers and doers. 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. We believe everyone plays an important role in making a 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.

What Records Management Compliance Department Does at Worldwide
TMF Operations handles the processing, maintenance, and archiving of all essential documents in strict accordance with pertinent Standard Operating Procedures, country‑specific regulations, and industry best practices. Throughout Worldwide Clinical Trials, our culture of collaboration and innovation propels us in our pursuit of excellence in clinical research and making a meaningful impact on every patient’s life. Roles within our TMF Operations department have a global scope, with the opportunity to regularly collaborate with members of the Worldwide Project Team.

What You Will Do

• Perform RMC Lead Activities for 1‑3 studies.
• Support TMF set‑up, coordinate ‘Requests for Sites to be added in eTMF’ between Project Teams (PT) and eTMF administrators; review eTMF access and coordinate updates, as necessary.
• Provide Subject Matter Expert (SME) support for Project Teams and Sponsor related to TMF.
• Oversee the QC process and ensure the RMC is on track (compliant with timelines and documentation) and follow up on non‑compliance accordingly.
• Prepare, maintain, and share TMF metrics and spreadsheets for assigned studies with Project Teams and Sponsors. Review TMF Key Performance Indicators (KPIs) and ensure that TMF KPIs are in compliance.
• Support Regulatory and Sponsor audits and audit finding resolution, where necessary.

What You Will Bring To The Role

• Excellent written and verbal communication skills to clearly and concisely present information.
• Strong interpersonal skills.
• Ability to handle multiple, highly detailed tasks with exceptional accuracy.
• Strong planning and organizational skills.
• Proficiency in Microsoft Word and Excel.

Your Experience
University degree preferred (Life Science desirable). 1‑3 years of relevant experience. Knowledge of working within a highly regulated industry or experience in CRO/Pharmaceutical Company industry.

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.