**Job Title:** Document Operations Specialist
As a key member of the team, you will play a vital role in ensuring the accuracy and compliance of essential documents. This includes processing, reviewing, and resolving rejected Trial Master File (TMF) documents for complex studies or Sponsor portfolio of studies.
The ideal candidate will have proficiency in using electronic document repositories or eTMFs, as well as strong interpersonal skills to communicate effectively with the RMC Lead and other team members.
* Key Responsibilities:
* Process and review TMF documents to ensure adherence to regulatory and industry best practices.
* Perform periodic quality control checks to identify any issues or trends.
* Collaborate with various electronic document management systems to classify and process essential documents.
* Communicate directly with the RMC Lead to report any concerns or issues.
Required Skills and Qualifications:
* Proficiency in Electronic Document Management Systems: Experience working with eTMFs and document recognition skills.
* Strong Interpersonal Skills: Ability to work in a fast-paced environment and communicate effectively with team members.
* Sound Judgment: Capacity to identify decisions requiring supervisory approval.
* Microsoft Office Skills**: Proficiency in Microsoft Word and Excel.
Your Background:
* Education**: University Degree preferred, with a focus on Life Sciences desirable.
* Experience**: 1-2 years of relevant experience in a highly regulated industry.