Job Summary:
This role involves the management of essential documents in compliance with regulatory requirements and industry best practices. The Associate will be responsible for processing, maintaining, and archiving Trial Master File (TMF) documents, as well as performing periodic quality control to ensure adherence to regulatory guidelines.
Main Responsibilities:
* Process and review TMF documents in both electronic and hard copy formats
* Resolve rejected documents and escalate any quality issues
* Work with various electronic document management systems to classify and process essential documents
* Communicate with RMC Lead to report trends and issues relevant to the TMF
Key Skills and Qualifications:
* Proficiency in using electronic document repositories or eTMFs
* Strong interpersonal skills in a fast-paced environment
* Sound judgment and decision-making skills
* Proficiency in Microsoft Word and Excel
Requirements:
* University degree preferred (Life Science desirable)
* 1-2 years of relevant experience
* Knowledge of working within a highly regulated industry