Job Description
The Associate II, TMF Operations is a critical role in ensuring the management of essential documents. This position requires a high degree of organization and attention to detail to ensure compliance with relevant Standard Operating Procedures, ALCOA principles, country regulations and industry best practices.
Key Responsibilities:
* Process, review and resolve rejected Trial Master File (TMF) documents for complex studies or Sponsor portfolios.
* Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor and industry best practices.
* Work with electronic document management 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 in a timely manner to RMC Lead.
Requirements:
* Proficiency in use of 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.
Education and Experience:
* University Degree preferred (Life Science desirable).
* 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry (desirable).