Senior Clinical Systems and Records Management Specialist
Experience
erves as an experienced Subject Matter Expect for Clinical Systems (e.g. CTMS and eTMF) and provides leadership support for clinical system set-up, user account management and review, ongoing maintenance, closure and archival activities
Support the study team to define, create and generate specific Clinical System reports and assist the Clinical Study Team with accurately updating and maintaining clinical systems and processes that track site and study conduct, compliance and performance within project timelines
Assist and provide operational input to the clinical team in the preparation, filing, and archiving of the Trial Master File documentation and reports according to the scope of work, Trial Master File Plan and standard operating procedures.
Lead the periodic review of the Trial Master File, in close collaboration with the Study Manager, and assess for completeness, communicating trends and supporting GCP inspection readiness activities.
Organize, maintain and participate in audits and close out of the Trial Master File (TMF/eTMF)
Assist with Clinical System Change Control activities including performing User Acceptance Testing activities
Assist with study start-up activities and tracking study metrics (e.g. feasibility data, ICF review, and Trial Master File (TMF) tracking)
Collect, track and conduct secondary review for completeness of site regulatory documents for Investigational Product (IP) release.
Assist with the development of study tools and templates for clinical trial start up activities including providing input into the Trial Master File Plan
Assist with the organization of internal team meetings, investigator meetings and other trial-specific meetings including taking meeting minutes, where required
Support the development, creation and shipping of site specific Investigator Site File, Pharmacy Binders and other site supplies, as required
Communicates directly with sites, Site Management Organizations (SMOs), Contracted Vendors and field CRAs, where required, to obtain updated information, essential documents to assist with driving start-up, study conduct, and/or close out activities
May accompany CRAs on site visits to assist with Investigator Site File review
Serves as an experienced role model and mentor others on specific tasks, systems or processes and sharing lessons learned while interacting in a positive professional manner
Support departmental process improvement efforts
May perform other assigned administrative duties to support team members with clinical trial execution.
