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

REQUIRED SKILLS

• Superior communication skills in English (verbal and written)

• Strong PowerPoint skills

• Ability to effectively multitask in order to simultaneously execute multiple projects

• Exceptional problem-solving/critical thinking skills

• Ability to maintain professionalism in all situations, especially under tight deadlines

• Good interpersonal skills

• Ability to build relationships with clients and co-workers

• Detail-orientated and well organize

REQUIRED EXPERIENCE AND QUALIFICATIONS

• Proven knowledge the Life Sciences industry (pharmaceutical, biotechnology or CRO experience preferred) • Good experience with TMF documents including filing and QC

• 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)

DESIRED SKILLS AND EXPERIENCE

• Experience working with eTMF or other eClinical systems such CTMS, SSU, eTMFs as Veeva Vault or Wingspan IQVIA TMF