Job Description
The Associate II, TMF Operations is responsible for the processing and maintenance of essential documents in compliance with relevant Standard Operating Procedures, ALCOA principles, country regulations, and industry best practices.
* Process, review, and resolve rejected Trial Master File (TMF) documents in electronic and hard copy formats.
* Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
Key Responsibilities:
* Review and classify Essential Documents using Electronic Document Management and eTMF Systems.
* 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:
* Proficiency in using electronic document repositories or eTMFs and document recognition skills.
* Strong interpersonal skills in fast-paced environments.
* Sound judgment and ability to identify decisions requiring supervisory approval.
Preferred Qualifications:
* University Degree (Life Science desirable).
* 1-2 years of relevant experience.
* Knowledge of working within highly regulated industries.