Job Description
The role of the Associate II, TMF Operations is a critical position within our organization. The successful candidate will be responsible for ensuring the accuracy and completeness of Trial Master Files (TMFs) in compliance with regulatory requirements and industry best practices.
Key Responsibilities
* Process and review TMF documents, including electronic and hard copy formats, to ensure adherence to regulatory and industry standards.
* Perform periodic quality control checks on TMFs to identify trends and issues that require attention.
* Work with various Electronic Document Management Systems (EDMS) to review, classify, and process essential documents.
* Communicate directly with RMC Leads to report any issues or concerns related to TMFs.
* Escalate any quality issues in a timely manner to ensure prompt resolution.
Requirements
* Proficiency in using EDMS and document recognition skills are essential for this role.
* Strong interpersonal skills are required to work effectively in a fast-paced environment.
* Sound judgment and decision-making skills are necessary to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Office applications, particularly Word and Excel, is also required.
Education and Experience
* A university degree in a life science field is preferred, but not mandatory.
* 1-2 years of relevant experience in a highly regulated industry is desirable.