Worldwide Clinical Trials is looking for an Associate I, TMF Operations to join our team on a fixed-term basis. In this role, you will fulfill the critical TMF Approver function, ensuring the integrity and quality of our Trial Master File documents. You’ll contribute to our mission of improving lives by enabling the success of clinical research.
What You'll Do
- Fulfill the ‘TMF Approver’ role as defined by Standard Operating Procedures and working practices.
- Process, review, and resolve rejected Trial Master File documents for multiple studies in electronic and hard copy formats.
- Work with Electronic Document Management and eTMF systems to review, classify, and process Essential Documents.
- Communicate directly with the RMC Lead to report trends and issues relevant to the TMF.
- Escalate any TMF quality issues in a timely manner.
- Provide administrative support, including filing and maintaining internal documents on study SharePoint.
- Perform additional tasks as assigned by your Line Manager.
What We're Looking For
- Data collection, indexing, and editing skills, with the ability to adhere to standardized document naming conventions.
- Excellent written and verbal communication skills to clearly and concisely present information.
- Ability to work with internal teams, execute tasks under general direction, and seek assistance as needed.
- Sound judgment and the ability to identify decisions requiring supervisory approval.
- Proficiency in Microsoft Word and Excel.
- Ability to develop proficiency in an electronic document repository or eTMF, and document recognition skills.
- A general understanding of clinical research principles and processes.
- 0-1 year of relevant experience.
Nice to Have
- A University Degree preferred, ideally in a Life Science field.
- Knowledge of working within a highly regulated industry.
Technical Stack
- Microsoft Word, Microsoft Excel, Electronic Document Management Systems, electronic TMF Systems, SharePoint
Team & Environment
Roles within our TMF Operations department have a global scope, with the opportunity to regularly collaborate with members of the Worldwide Project Team. You will report directly to your Line Manager.
Work Mode
This is a remote position open to candidates based in the EU and LATAM regions.
Worldwide Clinical Trials is an equal opportunity employer committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that promotes collaboration and creativity.
