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 patients' lives through new and innovative therapies.
Why Worldwide
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 an Associate II, TMF Operations does at Worldwide
TMF Operations handles the processing, maintaining, and archiving all essential documents, strictly following 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
The Associate II, TMF Operations, is responsible for the processing, maintaining, and archiving all essential documents in compliance with the relevant Standard Operating Procedures, ALCOA principles, country regulations, and industry best practices.
The Associate will support the delivery of department objectives in ensuring the management of essential documents.
This is a global role and will require working with Worldwide Project Team members.
What you will bring to the role
- Fulfill 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 portfolios of studies both in an electronic and hard copy format.
- Prepare periodic TMF Quality Control checklists for review by the Project Team review.
- Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
- Work with various Electronic Document Management and electronic TMF Systems to review, classify, and process Essential Documents.
- Communicate directly with the RMC Lead to report trends and issues relevant to the TMF.
- Escalate any TMF Quality issues promptly to RMC Lead.
- Deputize for RMC Lead where required.
- Provide administrative support for the RMC Lead, including but not limited to filing and maintaining internal documents on study SharePoint (TMF Quality Control checklists and different trackers).
- Perform additional tasks as assigned by their Line Manager.
Your experience
- Possesses data collection, indexing, and editing skills, including adhering to standardized document naming conventions.
- Proficiency in using an electronic document repository or eTMF and document recognition skills.
- Develop proficiency in cross checks and co-dependencies of the eTMF documents across different.
- Work with internal teams and can execute tasks under general direction, seeks assistance as needed.
- Display strong interpersonal skills in a fast-paced, deadline-oriented, rapidly changing environment.
- Exercise sound judgment and ability to identify decisions requiring supervisory approval.
- Handle multiple, highly detailed tasks with exceptional accuracy
- Demonstrate vital planning and organizational skills
- Demonstrate proficiency in Microsoft Word and Excel.
Your background
- University Degree preferred (Life Science desirable)
- Up to 1-2 years of relevant experience
- Knowledge of working within a highly regulated industry (desirable)
Why Worldwide
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 ! For more information on Worldwide, visit or connect with us on LinkedIn .
