Job Title: Associate II, TMF Operations
Working as an Associate II in TMF Operations involves a range of responsibilities including the processing, maintaining, and archiving of essential documents. This is crucial for ensuring compliance with regulatory requirements, industry best practices, and standard operating procedures.
Main Responsibilities:
* Review, classify, and process Trial Master File (TMF) documents, both electronic and hard copy, for complex studies or sponsor portfolios.
* Perform periodic quality control checks to ensure adherence to regulatory, ICH GCP, sponsor, and industry best practices.
* Utilize various Electronic Document Management systems to review, classify, and process Essential Documents.
* Communicate directly with the RMC Lead on trends and issues related to the TMF.
* Evaluate and escalate any TMF Quality issues in a timely manner.
Requirements:
* Possess proficiency in using an electronic document repository or eTMF, along with strong document recognition skills.
* Demonstrate excellent interpersonal skills in fast-paced environments with tight deadlines.
* Exhibit sound judgment and ability to identify decisions requiring supervisory approval.
* Showcase proficiency in Microsoft Word and Excel.
About You:
* Hold a University Degree, preferably in Life Sciences.
* Have 1-2 years of relevant experience.
* Possess knowledge of working within a highly regulated industry.