Senior Associate I, TMF Operations - UK - Remote

worldwide.com; United Kingdom; Remote; GBP 30,000 - 45,000; Full time

Job summary

A global clinical research organization is seeking a professional for the TMF Operations role, responsible for overseeing essential documents and ensuring compliance with regulations. The candidate should possess strong communication and organizational skills, along with expertise in TMF processes. The position requires a university degree, preferably in Life Sciences, with 1-3 years of relevant experience in a regulated environment. Join a collaborative team dedicated to improving lives worldwide.

Qualifications

• 1-3 years of relevant experience in a regulated industry.
• Knowledge of TMF operations and compliance.
• Experience in CRO/Pharmaceutical companies.

Responsibilities

• Perform RMC Lead Activities for 1-3 studies.
• Support TMF set-up and coordinate requests for sites.
• Provide SME support for Project Teams and sponsors.
• Oversee QC processes and compliance.
• Prepare and maintain TMF metrics for studies.

Skills

Excellent written and verbal communication skills

Strong interpersonal skills

Ability to handle multiple tasks with accuracy

Strong planning and organizational skills

Proficiency in Microsoft Word and Excel

Education

University Degree (Life Science desirable)

Job description

**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 over 3,500+ 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.**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 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 is what 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 makes sure 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 makes sure that TMF KPIs are in compliance.* Support Regulatory and Sponsor audits and audits 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 of CRO/Pharmaceutical Company industryWe love knowing that someone is going to have a better life because of the work we do.To view our other roles, check out our careers page at ! For more information on Worldwide, visit or connect with us on .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**.**