Judy Tonkin

Tmf Manager @Shionogi Inc. (U.S.)

Manages document control processes and systems for GCP activities in compliance with internal procedures and policies as well as regulatory requirements: • Maintains the eTMF records management system including secure storage, retrieval, retention, and destruction per Shionogi SOPs • Manages the day-to-day routing, review, approval, distribution and archival of clinical studies • Manages TMF Record integrity whether paper or electronic • Performs TMF Health Review, provides findings to the clinical team and provides support to the team to ensure compliance is maintained • Performs pre-Audit/Inspection review of TMF and Investigator Site File (ISF) • Provides TMF business guidance to Shionogi’s study teams, functional areas, and document users • Oversees the TMF migration process from CRO eTMF system to Shionogi eTMF system (Veeva Vault) for Record Management/Business group • Works to ensure successful eTMF system’s global implementation and assists in global TMF structure development • Organizes and leads the eTMF study team meetings • Serves as core team member in updating Shionogi’s TMF related SOPs, WIs and plans • Ensures high quality TMF set-up and management in collaboration with the Clinical Trial Manager • Organizes and provides TMF/eTMF process implementation training to all study teams and cross functional areas • Ensures TMF record management documents and processes are periodically reviewed for relevance • Provides support to clinical teams during regulatory inspections for record organization and retrieval • Prepares regular metrics and status reports on Document Control for Clinical Trial Management review • Trains and mentors study teams in TMF documentation, filing, and archiving • Follows up on open record management queries and ensures their full resolution