Associate II, TMF Operations

• Fulfil the "TMF Approver" and/or "TMF QC Reviewer" roles as defined by relevant SOPs and working practices
• Process, review, and resolve rejected Trial Master File (TMF) documents for complex studies or Sponsor portfolios in electronic and hard copy formats
• Prepare periodic TMF Quality Control checklists for Project Team review
• Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices
• Use Electronic Document Management and electronic TMF Systems to review, classify, and process Essential Documents
• Collaborate regularly with members of the Worldwide Project Team

• 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
• Display strong interpersonal skills in a fast-paced, deadline oriented, rapidly changing environment
• Handle multiple, highly detailed tasks with exceptional accuracy
• Demonstrate strong planning and organizational skills
• Demonstrate proficiency in Microsoft Word and Excel
• Develop proficiency in use of an electronic document repository or eTMF
• General understanding of clinical research principles and processes
• Up to 1-2 years of relevant TMF experience within the CRO/Pharma industry

• Diverse and inclusive work environment
• Collaborative and supportive teams
• Accessible leadership
• Equal employment opportunities
• Exceptional employee experiences