Lead eClinical Systems Analyst

OVERVIEW

The Lead eClinical Systems Analyst is a senior line management role. This role 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). This role assists

clients with trial management, as required by our clients. The person in this position is someone who is highly

experienced with eClinical systems, particularly the clinical trial process around the quality of the TMF. The Lead

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.

DESCRIPTION

• Line management, coaching and mentoring of eClinical Analysts in the assigned location/s

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

• Oversee 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

• Assist in 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 manager for further training evaluation

• May work with Study Owners (SO) 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

• Identify and report to SO/Clinical Document Lead /Project Manager/Client/Line 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 to senior leadership team

• 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)

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

• Superior problem-solving/critical thinking skills

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

• Superior interpersonal skills

• Superior proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint)

• Excellent managerial/leadership skills

REQUIRED EXPERIENCE AND QUALIFICATIONS

• Minimum of 5 years of experience in the Life Sciences industry (pharmaceutical, biotechnology or CRO experience preferred)

• Strong experience with TMF documents including creation, tracking, implementation, maintenance, and electronic filing and QC

• Experience in the use and development of hard copy files/electronic documentation and electronic TMF

• Strong working knowledge of ICH/GCP Guidelines

• Knowledge of clinical development phases and processes

• Line management or team lead experience

DESIRED SKILLS AND EXPERIENCE

• Ability to build relationships with clients and co-workers

• Detail-orientated and well organized

• Critical thinker

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

• Superior knowledge of the CDISC TMF Reference Model