About the Role
">
We are seeking a highly organized and detail-oriented individual to join our team as an Associate II, focusing on TMF Operations.
">
Key Responsibilities
">
">
* Process and review Trial Master File (TMF) documents in electronic and hard copy formats for complex studies or Sponsor portfolios.
">
* Perform periodic Quality Control checks to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
">
* Collaborate with various Electronic Document Management and eTMF Systems to review, classify, and process Essential Documents.
">
* Communicate trends and issues relevant to the TMF with RMC Leads and escalate Quality issues in a timely manner.
">
* Provide administrative support to RMC Leads, including filing and maintaining internal documents on study SharePoint.
">
">
Requirements
">
">
* Proficiency in using electronic document repositories or eTMFs, along with strong document recognition skills.
">
* Excellent interpersonal skills, ability to work in fast-paced environments, and make sound judgments.
">
* Proficiency in Microsoft Word and Excel.
">
">
Preferred Qualifications
">
">
* University Degree preferred, Life Science desirable.
">
* 1-2 years of relevant experience.
">
* Knowledge of working within highly regulated industries.
">