Job Description:
The Associate II, TMF Operations role is a critical position in the organization responsible for ensuring the management of essential documents. The job requires strong organizational and communication skills to support the delivery of department objectives.
Key Responsibilities:
* Process, review, and resolve rejected Trial Master File (TMF) documents in both electronic and hard copy formats.
* Perform periodic TMF Quality Control 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.
* Evaluate and escalate any TMF quality issues to RMC Lead in a timely manner.
Required Skills and Qualifications:
* Proficiency in using an electronic document repository or eTMF, 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.
Your Background:
* University Degree preferred, Life Science desirable.
* 1-2 years of relevant experience.
* Familiarity with working within a highly regulated industry, desirable.
About You:This role requires someone who can effectively manage multiple tasks, communicate clearly, and maintain high-quality work standards. If you have a passion for document management and are detail-oriented, this could be the ideal opportunity for you.