Job Description
The Associate II, TMF Operations role is a dynamic position that requires strong organizational and analytical skills to manage essential documents.
* This role involves processing, reviewing, and resolving rejected Trial Master File (TMF) documents in both electronic and hard copy formats for complex studies or Sponsor portfolios of studies.
* Periodic TMF Quality Control ensures adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
* Collaboration with various Electronic Document Management and electronic TMF Systems is necessary to review, classify, and process Essential Documents.
Key Responsibilities:
* Process and resolve rejected TMF documents.
* Perform periodic TMF Quality Control.
* Review and classify Essential Documents using Electronic Document Management and eTMF Systems.
* Communicate directly with RMC Lead to report trends and issues relevant to the TMF.
* Educate staff on document management processes.
* Escalate TMF quality issues to RMC Lead.
* Provide administrative support to RMC Lead.
Requirements
* Proficiency in Electronic Document Management and eTMF Systems.
* Strong interpersonal skills in a fast-paced environment.
* Sound judgment to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
* University degree preferred, Life Science desirable.
* 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry desirable.
Key Skills:
* Document recognition skills.
* Electronic document repository proficiency.
* Rapid decision-making in a deadline-oriented environment.
* Microsoft Office suite expertise.
Benefits and Qualifications:
* Knowledge of ICH GCP and regulatory requirements.
* Familiarity with SharePoint and other collaboration tools.
* Excellent communication and problem-solving skills.
Education and Experience:
* Relevant experience in a similar role.
* University degree in a related field.
About the Role
* This role supports the delivery of department objectives by ensuring efficient management of essential documents.
* The Associate II, TMF Operations role contributes to maintaining compliance with regulatory requirements.