Associate II, TMF Operations

Worldwide Clinical Trials; United States; Remote; USD 60,000 - 85,000; Full time

Job summary

Worldwide Clinical Trials in the United States is seeking a TMF Records Management Compliance professional to support Trial Master File processes, quality control, and regulatory compliance across studies. You will help ensure TMF integrity, and oversee document handling in electronic and paper formats.

The role emphasizes TMF approval and QC review, resolving document issues, and maintaining robust document management practices using eTMF systems.

Qualifications

• University degree preferred (Life Science desirable).
• Up to 1–2 years TMF experience in CRO/Pharma.

Responsibilities

• Fulfil the “TMF Approver” and/or “TMF QC Reviewer” roles as defined by SOPs and practices.
• Process, review, and resolve rejected TMF documents for complex studies or Sponsor portfolio, in electronic and hard copy formats.
• Prepare periodic TMF Quality Control checklists for review by Project Team.
• Perform periodic TMF Quality Control to ensure regulatory, ICH GCP, Sponsor, and industry best practices.
• Work with Electronic Document Management and electronic TMF Systems to review, classify and process Essential Documents.

Skills

Data collection

Indexing

Editing skills

Written comms

Interpersonal skills

Attention to detail

MS Word

MS Excel

eTMF systems

Document management

Education

University degree preferred

Life science background desirable

TMF experience in CRO/Pharma (1–2 years)

Tools

Electronic document management systems

eTMF experience

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!

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 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

• University Degree preferred (Life Science desirable)

• Up to 1-2 years of relevant TMF experience within the CRO/Pharma industry

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’reon a mission to hire thevery bestand 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.