Job Overview:
Associate II, TMF Operations
The Associate II, TMF Operations is responsible for processing, maintaining and archiving of all essential documents in compliance with relevant Standard Operating Procedures, ALCOA principles, country regulations and industry best practice.
This global role requires working with Worldwide Project Team members to ensure the management of essential documents.
Key Responsibilities:
* Process, review, and resolve rejected Trial Master File (TMF) documents in electronic and hard copy formats 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 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.
* Educate RMC Lead on any TMF Quality issues and provide timely escalation as necessary.
* Provide administrative support including filing and maintaining internal documents on study SharePoint (TMF Quality Control checklists and different trackers).
About You:
* You will have proficiency in an electronic document repository or eTMF, and document recognition skills.
* You will possess strong interpersonal skills in a fast-paced, deadline-oriented environment.
* You will be able to make sound judgments and identify decisions requiring supervisory approval.
* You will have proficiency in Microsoft Word and Excel.
Your Qualifications:
* A University Degree is preferred, particularly in Life Sciences.
* You will have 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry is desirable.