Associate I, TMF Operations - Europe - Remote

Worldwide Clinical Trials; Georgia; On-site; USD 45,000 - 55,000; Full time

Job summary

A clinical research organization in Georgia is seeking a TMF Operations professional to fulfill the TMF Approver role and ensure compliance with document processing standards. The ideal candidate should possess a university degree, relevant skills in data handling, and excellent communication abilities. Responsibilities include document review, quality issue escalation, and providing support to the RMC Lead. An inclusive workplace that values diverse talent and focuses on exceptional employee experiences is prioritized.

Qualifications

• Up to 0-1 year of relevant experience in a highly regulated industry.
• Ability to adhere to standardized document naming conventions.
• General understanding of clinical research principles and processes.

Responsibilities

• Fulfil the TMF Approver role as per SOP and working practices.
• Process, review, and resolve TMF document issues.
• Communicate trends and issues to RMC Lead.
• Provide administrative support for the RMC Lead.

Skills

Data collection

Indexing

Editing skills

Written communication

Verbal communication

Microsoft Word

Microsoft Excel

Education

University Degree in Life Science

Tools

Electronic Document Management Systems

eTMF Systems

Job description

What Records Management Compliance Department Does At Worldwide

TMF Operations handles the processing, maintenance and archiving of all essential documents in strict accordance with Standard Operating Procedures, country‑specific regulations and industry best practices. Throughout Worldwide Clinical Trials, our culture of collaboration and innovation propels us in pursuing 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 opportunities to collaborate regularly with members of the Worldwide Project Team.

What You Will Do

• Fulfil the “TMF Approver” role as defined by the relevant Standard Operation Procedure(s) (SOP) and working practices.
• Process, review, and resolve rejected Trial Master File (TMF) documents for multiple studies in both electronic and hard‑copy format.
• Work with a variety of Electronic Document Management and eTMF Systems to review, classify and process Essential Documents.
• Communicate directly with RMC Lead to report trends and issues relevant to the TMF.
• Escalate any TMF Quality issues in a timely manner to RMC Lead.
• Provide administrative support for the RMC Lead including filing and maintaining internal documents on study SharePoint (TMF Quality Control checklists and different trackers).
• Perform additional tasks as assigned by the Line Manager.

What You Will Bring To The Role

• University Degree preferred (Life Science desirable).
• Up to 0‑1 year of relevant experience.
• Knowledge of working within a highly regulated industry (desirable).
• 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.
• Work with internal teams and can execute tasks under general direction, seeking assistance as needed.
• Exercise sound judgment and ability to identify decisions requiring supervisory approval.
• Demonstrate proficiency in Microsoft Word and Excel.
• Develop proficiency in use of an electronic document repository or eTMF, and document recognition skills. General understanding of clinical research principles and processes.

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 any class protected by applicable law.