Senior eClinical Systems Analyst

The Senior eClinical Systems Analyst has good knowledge of clinical trial processes and associated systems utilized. With core skills around all clinical processes, they work on multiple projects to ensure a complete, contemporaneous and accurate TMF across our clients’ clinical trials and programs.

Senior 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 TMF, Study Start up (SSU) and Clinical Trial Management System (CTMS). The person in this position will be someone who is highly experienced with eClinical systems, particularly the clinical trial process around the quality of the TMF.

Responsibilities

• Create and complete billable TMF quality reviews to ensure document content and metadata application are accurate and to ensure documentation is present/complete in the TMF

• Periodic quality reviews for each active study site for all regulatory documents, including: IRB Renewal, IRB Protocol Approval, Informed Consent Review, Signature of Co-Investigator, IRB Membership list, Lab Normal, CAP, CLIA, 1572 Form, Agreements, PI CVs

• Complete regulatory document review and compilation of documents for FDA submissions using GCP and ICH guidelines

• Draft, review and approve TMF Quality plans and reports and reconciliation of findings

• Communicate all systematic filing issues to the manager for further training evaluation

• May work with Study Owners with all start up, maintenance and close out activities in regards to the eTMF ongoing user management

• Assume responsibility for creation and, or maintenance of events/placeholders or equivalent in the eTMF from time to time

• 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 timelines

• Storyboard support and maintenance to assist with inspection readiness CTMS data entry and analysis on behalf of CTMS and enterprise clients

• Line management, coaching and mentoring of eClinical Analysts

• Complete all other tasks that are deemed appropriate for this role and assigned by the manager

Required Skills, Experience and Qualifications

• 3 years+ of experience in the Life Sciences industry (pharmaceutical, biotechnology or CRO experience preferre

• Strong experience with TMF documents including filing and QC

• Proven experience in the use and development of electronic documentation and electronic TMF

• Strong working knowledge of ICH/GCP Guidelines

• Knowledge of clinical development phases and processes

• Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint

• Ability to build relationships with clients and co-workers

• Excellent leadership skills

• Detail-orientated and well organized

• Critical thinker