Associate I, TMF Operations

Worldwide Clinical Trials; Brasil; On-site; BRL 40,000 - 70,000; Full time

Benefits offered by this job

Sharepoint access

Job summary

Worldwide Clinical Trials is seeking a Records Management professional to handle TMF processes across multiple studies. The role involves reviewing and classifying TMF documents, ensuring compliance with SOPs, and collaborating with the RMC Lead to identify trends and issues.

A university degree and practical TMF experience are preferred. You will work within a globally involved TMF Operations team, supporting quality control and document management in a regulated CRO environment.

Qualifications

• University degree preferred.
• Minimum 6 months TMF experience.
• Experience in regulated CRO/Pharma industry preferred.
• Knowledge of documentation standards and controlled vocabularies.

Responsibilities

• Fulfil the TMF Approver role per SOPs and procedures.
• Process, review and resolve rejected TMF documents for multiple studies.
• Use electronic TMF systems to review, classify, and process essential documents.
• Report trends and issues to the RMC Lead.
• Escalate TMF quality issues in a timely manner.
• Provide admin support, e.g., SharePoint filing and trackers.
• Perform additional tasks as assigned by Line Manager.

Skills

Data entry

Documentation

Communication

MS Word

MS Excel

Attention to detail

Education

University degree preferred

Tools

eTMF

SharePoint

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

• 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 both in an electronic and hard copy format.
• Work with a variety of Electronic Document Management and electronic TMF 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 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.

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.
• Work with internal teams and can execute tasks under general direction, seeks 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.

What You Will Bring To The Role

• University Degree preferred
• Minimum 6 months of relevant TMF experience
• Knowledge of working within a highly regulated industry (preferably within CRO/Pharma industries)

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

We love knowing that someone is going to have a better life because of the work we do.

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.