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.
REQUIRED SKILLS:
Strong problem-solving and analytical skills, with the ability to think strategically and act tactically
Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint, and Teams)
Excellent customer service skills with the ability to balance multiple tasks
Superior written and spoken communication skills in English
Ability to work under pressure and meet deadlines
Ability to work in a global environment with internal and external partners
Knowledge of eTMF platforms and interoperability with clinical research systems
Aptitude for forging strong partnerships/relationships across the organization including operations, business development, production, and quality and customers.
REQUIRED EXPERIENCE & QUALIFICATION:
Minimum Bachelor’s degree to its equivalent in Clinical Research, Life Sciences or Business
Minimum 4 years’ experience in Trial Master File (TMF) or professional equivalent.