Document Control Specialist
This role is responsible for the processing, maintaining and archiving of all essential documents in compliance with relevant Standard Operating Procedures, ALCOA principles, country regulations and industry best practices.
The Document Control Specialist will support the delivery of department objectives in ensuring the management of essential documents. This is a global role that requires working with project team members across different regions.
Key Responsibilities:
* Process, review and resolve rejected Trial Master File (TMF) documents for complex studies or sponsor portfolios of studies both in electronic and hard copy formats.
* Perform periodic TMF Quality Control to ensure adherence to regulatory, 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.
* Escalate any TMF Quality issues in a timely manner to the RMC Lead.
* Provide administrative support for the RMC Lead including but not limited to filing and maintaining internal documents on study SharePoint (TMF Quality Control checklists and trackers).
Requirements:
* Proficiency in use of an electronic document repository or eTMF, and document recognition skills.
* Strong interpersonal skills in a fast-paced, deadline-oriented, rapidly changing environment.
* Sound judgment and ability to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
Preferred Qualifications:
* University degree preferred (Life Science desirable)
* 1-2 years of relevant experience
* Knowledge of working within a highly regulated industry (desirable)