Job Overview
The Associate II, TMF Operations plays a critical role in ensuring the management of essential documents. This position requires attention to detail, strong organizational skills, and excellent communication abilities.
Key Responsibilities
* Process and review Trial Master File (TMF) documents in both electronic and hard copy formats.
* Perform periodic quality control checks to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
* Work with various Electronic Document Management and electronic TMF Systems to review, classify, and process Essential Documents.
* Communicate directly with RMC Lead to report trends and issues relevant to the TMF.
* Educate others on TMF Quality Control procedures and processes.
Requirements and Qualifications
* A university degree is preferred, with a focus on Life Sciences desirable.
* 1-2 years of relevant experience in a highly regulated industry.
* Proficiency in Microsoft Word and Excel is necessary.
Your Skills and Abilities
* Strong interpersonal skills are essential for success in this role.
* Excellent judgment and decision-making abilities are required.
* Ability to work in a fast-paced environment with multiple deadlines.