Associate II, TMF Operations -Europe/LATAM- Remote
Worldwide Clinical Trials · Zagreb, Zagreb, Croatia
- Hybrid
- Full-time
- $75,000 / year
- Zagreb, Zagreb, Croatia
Job highlights
- Process and review Trial Master File documents.
- Ensure adherence to regulatory best practices.
- Utilize electronic document management systems.
- Requires 1-2 years of TMF experience.
- University degree preferred in Life Science.
About the role
About Worldwide Clinical Trials
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" 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).
- 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.
Key skills/competency
- TMF Operations Associate II
- TMF Approver
- TMF QC Reviewer
- Clinical Research
- Document Management
- Regulatory Compliance
- ICH GCP
- CRO/Pharma Industry
- Data Collection and Indexing
- Electronic TMF Systems
Skills & topics
- TMF Operations Associate
- TMF
- Trial Master File
- Clinical Research
- CRO
- Pharma
- Document Control
- Regulatory Compliance
- ICH GCP
- eTMF
How to get hired
- Tailor your resume: Highlight your TMF experience and proficiency with electronic document systems.
- Emphasize regulatory knowledge: Showcase understanding of ICH GCP and industry best practices.
- Prepare for technical questions: Be ready to discuss your experience with TMF processes and tools.
- Express your passion: Convey your commitment to improving patient lives and clinical research.
- Network strategically: Connect with Worldwide Clinical Trials employees on LinkedIn for insights.
Technical preparation
Behavioral questions
Frequently asked questions
- What are the key responsibilities for a TMF Operations Associate II at Worldwide Clinical Trials?
- As a TMF Operations Associate II, you will be responsible for fulfilling TMF Approver and/or TMF QC Reviewer roles. This includes processing, reviewing, and resolving rejected Trial Master File documents, preparing TMF Quality Control checklists, performing periodic TMF Quality Control, and working with Electronic Document Management and eTMF systems.
- What qualifications are preferred for this TMF Operations role?
- Worldwide Clinical Trials prefers candidates with a University Degree, ideally in Life Science. Additionally, 1-2 years of relevant TMF experience within the CRO/Pharma industry is required.
- What skills are essential for success in the TMF Operations Associate II position?
- Essential skills include data collection, indexing, and editing, with a strong ability to adhere to document naming conventions. Excellent written and verbal communication, strong interpersonal skills, the ability to handle multiple detailed tasks with accuracy, planning and organizational skills, and proficiency in Microsoft Word and Excel are also crucial.
- Does Worldwide Clinical Trials offer remote work for the TMF Operations Associate II position?
- Yes, the TMF Operations Associate II position at Worldwide Clinical Trials is listed as a Remote role, indicated by 'Remote' in the job title.
- How does Worldwide Clinical Trials foster a positive work environment?
- Worldwide Clinical Trials prioritizes a diverse and inclusive environment that promotes collaboration and creativity. They are committed to enabling professionals from all backgrounds to succeed, creating a workplace where employees thrive and are inspired to do their best work.
- What is the importance of the TMF Operations department at Worldwide Clinical Trials?
- The TMF Operations department is critical for handling, maintaining, and archiving all essential documents in strict accordance with SOPs, regulations, and industry best practices. Their work ensures excellence in clinical research and a meaningful impact on patient lives.
- What kind of systems will I be working with as a TMF Operations Associate II?
- You will work with a variety of Electronic Document Management and electronic TMF (eTMF) Systems to review, classify, and process Essential Documents.