Job Title: Senior Document Specialist
Job Summary:
The Senior Document Specialist plays a pivotal role in ensuring the seamless processing, maintaining and archiving of essential documents. This global position requires collaboration with worldwide project team members to deliver department objectives.
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 guarantee adherence to regulatory, ICH GCP, Sponsor and industry best practices.
* Utilize 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 filing and maintaining internal documents on study SharePoint (TMF Quality Control checklists and trackers).
Requirements:
* Proficiency in using an electronic document repository or eTMF, and document recognition skills.
* Strong interpersonal skills in fast-paced, deadline-oriented, rapidly changing environments.
* 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)
This role offers the opportunity to work in a dynamic environment, leveraging strong organizational and communication skills to drive results.