Associate II, TMF Operations - LATAM - Remote

Worldwide Clinical Trials Limited; Polska; Hybrid; PLN 55,000 - 80,000; Full time

Job summary

Worldwide Clinical Trials Limited is seeking a Records Management professional to support TMF Operations in a CRO environment. The role involves handling TMF Approver and QC Reviewer duties, reviewing and resolving TMF documents, and preparing quality control checklists to ensure regulatory adherence across electronic and paper records.

Applicants should bring familiarity with TMF processes, strong documentation skills, and the ability to work in a fast-paced setting while maintaining accuracy

Qualifications

• Ability to adhere to standardized document naming conventions.
• Excellent written and verbal communication.
• Strong interpersonal skills in fast-paced environments.
• Handle multiple, detailed tasks with accuracy.
• Demonstrate strong planning and organizational skills.
• Proficiency in MS Word and Excel.

Responsibilities

• Fulfil the TMF Approver and/or TMF QC Reviewer roles as defined by SOPs.
• Process, review, and resolve rejected TMF documents for complex studies.
• Prepare periodic TMF Quality Control checklists for review by Project Team.
• Perform periodic TMF Quality Control to ensure regulatory compliance.
• Work with electronic and hard-copy TMF systems to review, classify and process documents.

Skills

Data collection

Indexing

Communication skills

Interpersonal skills

Planning & organization

Word & Excel

eTMF knowledge

Clinical research basics

Education

University degree

Tools

MS Word

MS Excel

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 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.

This is who we are. We’re a team of clinicians, scientists, and researchers who want to make healthcare better. We were founded on an unwavering commitment to authentic, personalized attention. And today, as CROs consolidate and the industry changes rapidly, that personalized attention is more important than ever. We all came to this industry for different reasons, from different walks of life. If you ask any one of us why we’re here, you’ll get a different answer. And that’s what makes us special.

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.