Job Title: Document Control Specialist
Key Responsibilities:
* Process, review and resolve rejected Trial Master File (TMF) documents in electronic and hard copy formats for complex studies and Sponsor portfolios.
* Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP and industry best practices.
* Review, classify and process Essential Documents using Electronic Document Management and eTMF Systems.
* Communicate directly with the RMC Lead to report trends and issues relevant to the TMF.
About This Role:
This is a global role that requires working with a Worldwide Project Team. The successful candidate will be responsible for managing essential documents in compliance with relevant SOPs, ALCOA principles, country regulations and industry best practices.
The Associate will provide administrative support to the RMC Lead, including filing and maintaining internal documents on study SharePoint. They will also work with various electronic document repositories and eTMFs to review, classify and process documents.
Requirements:
* Proficiency in use of an electronic document repository or eTMF, and document recognition skills.
* Strong interpersonal skills in a fast-paced, deadline-oriented environment.
* Sound judgment and ability to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
About You:
* University Degree preferred (Life Science desirable).
* 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry (desirable).
Working Conditions:
This role requires strong organizational skills and attention to detail. The successful candidate will be able to work independently and as part of a team to achieve project objectives.
They will also have excellent communication and interpersonal skills, with the ability to build relationships with stakeholders at all levels.
The role involves working with a variety of electronic systems and software, so proficiency in Microsoft Office and other tools is essential.