[Hiring] Associate I, TMF Operations @Worldwide Clinical Trials

Role Description

Fulfil the "TMF Approver" role as defined by the relevant Standard Operation Procedure(s) (SOP) and working practices.

• Process, review, and resolve rejected Trial Master File (TMF) documents, for multiple studies both in an electronic and hard copy format.
• Work with a variety of Electronic Document Management and electronic TMF Systems to review, classify and process Essential Documents.
• Communicate directly with RMC Lead to report trends and issues relevant to the TMF.
• Escalate any TMF Quality issues in a timely manner to 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 different trackers).
• Perform additional tasks as assigned by their Line Manager.

Qualifications

• University Degree preferred
• Minimum 6 months of relevant TMF experience
• Knowledge of working within a highly regulated industry (preferably within CRO/Pharma industries)

Requirements

• Possess data collection, indexing and editing skills, including ability to adhere to standardized document naming conventions.
• Possess excellent written and verbal communication skills to clearly and concisely present information.
• Work with internal teams and can execute tasks under general direction, seeks assistance as needed.
• Exercise sound judgment and ability to identify decisions requiring supervisory approval.
• Demonstrate proficiency in Microsoft Word and Excel.
• Develop proficiency in use of an electronic document repository or eTMF, and document recognition skills.
• General understanding of clinical research principles and processes.

Benefits

• We love knowing that someone is going to have a better life because of the work we do.