Trial Master File (TMF) Senior Support Analyst

OVERVIEW

The Trial Master File Senior Support Analyst (TMF SSA) is the Quality Control Expert and ensures accuracy and completeness of all clinical documentation within the TMF and is expected to perform these responsibilities independently. This role is also tasked with mentoring TMF Associate Support Analysts (TMF ASA). The clinical trial documentation must be consistent with the Trial Master File Specifications, submission/inspection readiness criteria and comply with LMKs (or clients) SOPs and regulatory requirements and provides updates to leadership, as relevant.

DESCRIPTION

- Perform document level Quality Checks

- Index and/or activate documents in an eTMF.

- Migrate Paper/Electronic TMFs

- Provide Audit/Inspection support

- Perform TMF Quality Reviews

- Remediate findings resulting from TMF Quality Reviews

- Generate reports and metrics

- Author and maintain TMF Management Plans and management tools

- Create and maintain milestones, events and placeholders or equivalent in the eTMF

- Create and maintain storyboard(s)

- Meet with study team(s) to understand events/activities that would impact the TMF

- Support LMK TMF Project Manager with performing TMF Support Analyst oversight and quality spot checks

- Serve as a TMF Subject Matter Expert (SME)

- Escalate issues to LMK TMF Project Manager(s), as appropriate

- Maintain any and all documentation to evidence the above

- Complete all other tasks that are deemed appropriate for this role and assigned by the manager/supervisor.