Job Description:
The Associate II, TMF Operations plays a crucial role in the management of essential documents within a highly regulated industry. Key responsibilities include processing, maintaining, and archiving Trial Master File (TMF) documents to ensure compliance with relevant Standard Operating Procedures, ALCOA principles, country regulations, and industry best practices.
This is a global role that requires collaboration with Worldwide Project Team members to achieve departmental objectives. The successful candidate will support the delivery of high-quality TMF services by performing periodic Quality Control checks, escalating issues in a timely manner, and providing administrative support to the RMC Lead.
Key Responsibilities:
* Process, review, and resolve rejected TMF documents for complex studies or Sponsor portfolios in electronic and hard copy formats.
* Perform periodic TMF Quality Control to ensure adherence to regulatory requirements, 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 the RMC Lead to report trends and issues relevant to the TMF.
* Educate team members on proper document handling and classification procedures.
Requirements:
* Proficiency in using an electronic document repository or eTMF, as well as document recognition skills.
* Strong interpersonal skills to navigate fast-paced, deadline-oriented environments effectively.
* Sound judgment to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
* University Degree preferred; Life Science desirable.
* 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry is beneficial.
About the Role:
This role offers an excellent opportunity for candidates seeking a challenging position in a dynamic environment. If you possess strong organizational skills, attention to detail, and excellent communication skills, we encourage you to apply.