About the role

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

Fulfil the "TMF Approver" and/or "TMF QC Reviewer" roles as defined by the relevant Standard Operation Procedure(s) (SOP) and working practices.

Process, review, and resolve rejected Trial Master File (TMF) documents, for complex studies or Sponsor portfolio of studies both in an electronic and hard copy format.

Prepare periodic TMF Quality Control checklists for review by Project Team review.

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

What you will bring to the role

Possess data collection, indexing and editing skills, including ability to adhere to standardized document naming conventions

Possess excellent written and verbal communication skills to clearly and concisely present information

Display strong interpersonal skills in a fast-paced, deadline oriented, rapidly changing environment

Handle multiple, highly detailed tasks with exceptional accuracy. Demonstrate strong planning and organizational skills

Demonstrate proficiency in Microsoft Word and Excel

Develop proficiency in use of an electronic document repository or eTMF. General understanding of clinical research principles and processes

Your experience

Minimum 6 months of administrative experience, preferably but not strictly in the CRO or Pharma industry

Knowledge of working within a highly regulated industry (desirable)

A strong, long‑term interest in administrative‑focused work, with close attention to detail and comfort handling routine, process‑driven tasks

We 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 Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

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.

Aplyr's read

Worldwide Clinical Trials is a dynamic CRO offering comprehensive clinical development services, attracting professionals passionate about advancing pharmaceutical and biotechnology research.
Synthesized from recent postings & public sources

What's promising

•Strong global presence with remote roles in diverse locations like the US, Europe, and Australia.
•Focus on specialized areas such as neurology and oncology enhances expertise and innovation.
•Offers a wide range of roles, from project management to pharmacovigilance, catering to varied career interests.

What to watch

•Remote work may pose challenges in team cohesion and communication.
•High specialization could limit opportunities for those seeking broader industry experience.
•Limited public information about company culture and employee satisfaction.

Why Worldwide Clinical Trials

•Emphasizes early-phase clinical development, distinguishing it from many competitors.
•Combines global reach with niche expertise in clinical assessment technologies.
•Provides tailored services to pharmaceutical, biotechnology, and medical device sectors, ensuring diverse project exposure.

Aplyr’s read is generated by AI from public sources. Was it useful?

About Worldwide Clinical Trials

Worldwide Clinical Trials

worldwide.com

View company

Worldwide Clinical Trials is a full-service contract research organization (CRO) that provides clinical development services to the pharmaceutical, biotechnology, and medical device industries.