eClinical Systems Analyst

OVERVIEW

The eClinical Systems Analyst has good knowledge of clinical trial processes and associated systems utilized. With core skills around Trial Master File (TMF) processes they work as support to Study Owners to ensure a complete, contemporaneous and accurate TMF across our clients' clinical trials and programs. The eClinical Systems Analyst is responsible for assisting clients with the development, maintenance and closeout of clinical trials, using a number of eClinical systems including but not limited to : - e (electronic) TMF, Study Start up (SSU) and Clinical Trial Management System (CTMS). The person in this position will be someone who is experienced with eClinical systems, particularly the clinical trial process including management of the TMF.

DESCRIPTION

• Work with Study Owners with all start up, maintenance and close out activities in regards to the TMF
• eTMF ongoing user management
• May be responsible for creation and or maintenance of events / placeholders or equivalent in the eTMF
• Create and complete TMF quality reviews to ensure document content and metadata application are accurate and to ensure documentation is present / complete in the TMF
• Communicate all systematic filing issues to the manager for further training evaluation
• Periodic quality reviews for each active study site for all regulatory documents, including : Institutional Review Board (IRB) Renewal, IRB Protocol Approval, Informed Consent Review, Signature of Co-Investigator, IRB Membership list, Lab Normal, College of American Pathologists (CAP), Clinical Laboratory Improvements Amendments (CLIA), 1572 Form, Agreements, Principal Investigator (PI) CVs
• Draft, review and approve TMF Quality plans and reports and reconciliation of findings
• Assist in regulatory document review and compilation of documents for FDA submissions using GCP and ICH guidelines
• Identify and report to Study Owner, Clinical Document Lead, Project Manager, Client and, or Manager on TMF trending issues / concerns, determining resolutions and course of actions
• Provide support on metrics and report preparation for TMF Key Performance Indicators (KPIs) - completeness, quality and timeliness
• Storyboard support and maintenance to assist with inspection readiness
• Clinical Trial Management System (CTMS) data entry and analysis on behalf of CTMS and enterprise clients
• Meeting minutes and agendas
• Complete all other tasks that are deemed appropriate for this role and assigned by the manager / supervisor.

Skills Required

ICH guidelines, data entry and analysis, regulatory document review, metrics and report preparation