TMF Associate Support Analyst

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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 Reviews
• Remediate findings resulting from TMF Quality Reviews
• Perform document level Quality Checks
• Index and/or activate documents in an eTMF.
• Migrate Paper/Electronic TMFs
• Provide Audit/Inspection support.
• Author and maintain TMF Management Plans
• Generate 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 skills
• Proficiency in MSOffice Suite (i.e., Outlook, Word, PowerPoint, Excel)

4.0       REQUIRED EXPERIENCE AND QUALIFICATIONS

• Bachelor’s Degree or equivalent
• 2 years of TMF Experience or professional equivalent

5.0       DESIRED SKILLS AND EXPERIENCE

• Familiarity with Smartsheet preferred.
• GCP Certification preferred.