Job Description
About the Role
We are seeking an experienced professional to join our team as a TMF Operations Associate II. The successful candidate will be responsible for processing, maintaining and archiving essential documents in compliance with regulatory requirements.
Key Responsibilities
* Process and review Trial Master File (TMF) documents in electronic and hard copy formats.
* Perform periodic Quality Control checks to ensure adherence to regulations and industry best practices.
* Work with Electronic Document Management Systems to review, classify and process Essential Documents.
* Communicate with team members to report trends and issues relevant to the TMF.
* Escalate Quality issues in a timely manner.
Requirements
* Proficiency in electronic document repositories and document recognition skills.
* Strong interpersonal skills in a fast-paced environment.
* Sound judgment and decision-making skills.
* 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).