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:
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Perform document level Quality Checks
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Index and/or activate documents in an eTMF.
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Migrate Paper/Electronic TMFs
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Provide Audit/Inspection support
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Perform TMF Quality Reviews
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Remediate findings resulting from TMF Quality Reviews
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Generate reports and metrics
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Author and maintain TMF Management Plans and management tools
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Create and maintain milestones, events and placeholders or equivalent in the eTMF
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Create and maintain storyboard(s)
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Meet with study team(s) to understand events/activities that would impact the TMF
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Support LMK TMF Project Manager with performing TMF Support Analyst oversight and quality spot checks
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Serve as a TMF Subject Matter Expert (SME)
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Escalate issues to LMK TMF Project Manager(s), as appropriate
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Maintain any and all documentation to evidence the above
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Complete all other tasks that are deemed appropriate for this role and assigned by the manager/supervisor.
REQUIRED SKILLS:
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Strong problem-solving and analytical skills, with the ability to think strategically and act tactically
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Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint, and Teams)
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Excellent customer service skills with the ability to balance multiple tasks
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Superior written and spoken communication skills in English
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Ability to work under pressure and meet deadlines
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Ability to work in a global environment with internal and external partners
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Knowledge of eTMF platforms and interoperability with clinical research systems
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Aptitude for forging strong partnerships/relationships across the organization including operations, business development, production, and quality and customers.
REQUIRED EXPERIENCE & QUALIFICATION:
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Minimum Bachelor’s degree to its equivalent in Clinical Research, Life Sciences or Business
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Minimum 4 years’ experience in Trial Master File (TMF) or professional equivalent.
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