Job Title: Associate II, TMF Operations
Description:
We are seeking a highly skilled and detail-oriented individual to join our team as an Associate II, TMF Operations. In this role, you will be responsible for the processing, maintaining, and archiving of essential documents in compliance with regulatory requirements, industry best practices, and company policies.
Your Responsibilities:
* Document Processing: You will process, review, and resolve rejected Trial Master File (TMF) documents in electronic and hard copy formats, ensuring accuracy and adherence to regulatory requirements.
* TMF Quality Control: You will perform periodic quality control checks on TMFs to ensure compliance with regulatory, ICH GCP, Sponsor, and industry best practices.
* Electronic Document Management: You will work with various electronic document management systems to review, classify, and process essential documents.
* Communication: You will communicate directly with RMC Leads to report trends and issues relevant to TMFs.
* Escalation: You will escalate any TMF quality issues in a timely manner to RMC Leads.
* Administrative Support: You will provide administrative support to RMC Leads, including filing and maintaining internal documents on study SharePoint.
Your Skills and Qualifications:
* Proficiency in Electronic Document Management Systems: You should have proficiency in using electronic document repositories or eTMFs and possess strong document recognition skills.
* Interpersonal Skills: You should have strong interpersonal skills to effectively communicate with colleagues in a fast-paced, deadline-oriented environment.
* Decision-Making: You should have sound judgment and the ability to identify decisions requiring supervisory approval.
* Technical Skills: You should be proficient in Microsoft Word and Excel.
Your Background:
* Education: A university degree is preferred, with life science being desirable.
* Experience: You should have 1-2 years of relevant experience working within a highly regulated industry.