Job Description
* We are seeking a highly organized and detail-oriented professional to join our team as an Associate II, TMF Operations.
About the Role
The Associate II, TMF Operations will be responsible for ensuring the accuracy and completeness of trial master file documents in compliance with regulatory requirements. This role requires strong analytical skills, attention to detail, and excellent communication abilities.
Main Responsibilities
* Process and review trial master file documents in electronic and hard copy formats.
* Perform periodic quality control checks to ensure adherence to regulatory and industry best practices.
* Collaborate with various systems to review, classify, and process essential documents.
* Communicate trends and issues relevant to the trial master file to the RMC Lead.
* Escalate any quality issues in a timely manner.
* Provide administrative support to the RMC Lead, including filing and maintaining internal documents.
Requirements
* Proficiency in using electronic document repositories and document recognition skills.
* Strong interpersonal skills in a fast-paced environment.
* Sound judgment and ability to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
Education and Experience
* University degree preferred (life science desirable).
* 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry (desirable).