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1.0       OVERVIEW

LMK’s TMF Support Analyst is the Quality Control Expert. This role ensures accuracy and completeness of all clinical

documentation within the TMF. 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.

2.0       DESCRIPTION

Perform TMF Quality ReviewsRemediate findings resulting from TMF Quality ReviewsPerform document level Quality ChecksIndex and/or activate documents in an eTMF.Migrate Paper/Electronic TMFsProvide Audit/Inspection support.Author and maintain TMF Management PlansGenerate reports and metrics.Serve as a TMF Subject Matter Expert (SME)Other activities as directed by the Project Lead

3.0       REQUIRED SKILLS

Capability to self-supervise/work remotely.Capability to work in a global environment with internal and external partners.Fluency in English; strong written and verbal communications skillsProficiency in MSOffice Suite (i.e., Outlook, Word, PowerPoint, Excel)

4.0       REQUIRED EXPERIENCE AND QUALIFICATIONS

Bachelor’s Degree or equivalent2 years of TMF Experience or professional equivalent

5.0       DESIRED SKILLS AND EXPERIENCE

Familiarity with Smartsheet preferred.GCP Certification preferred.