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.

DESCRIPTIO

• NLine management, coaching and mentoring of eClinical Analysts in the assigned location/
• sOversee, 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 TM
• FOversee 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 CV
• sAssist in regulatory document review and compilation of documents for FDA submissions using GCP and ICH guideline
• sDraft, review and approve TMF Quality plans and reports and reconciliation of finding
• sCommunicate all systematic filing issues to manager for further training evaluatio
• nMay work with Study Owners (SO) with all start up, maintenance and close out activities in regards to the TMF eTMF ongoing user managemen
• tMay be responsible for creation and or maintenance of events/placeholders or equivalent in the eTM
• FIdentify and report to SO/Clinical Document Lead /Project Manager/Client/Line Manager on TMF trending issues/concerns, determining resolutions and course of action
• sProvide support on metrics and report preparation for TMF Key Performance Indicators (KPIs) - completeness, quality and timeliness to senior leadership tea
• mComplete all other tasks that are deemed appropriate for this role and assigned by the manager/superviso

rJob requirement

sREQUIRED SKILL

• SSuperior communication skills in English (verbal and written
• )Ability to effectively multitask in order to simultaneously execute multiple project
• sSuperior problem-solving/critical thinking skill
• sAbility to maintain professionalism in all situations, especially under tight deadline
• sSuperior interpersonal skill
• sSuperior proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint
• )Excellent managerial/leadership skill

s
REQUIRED EXPERIENCE AND QUALIFICATIO

• NSMinimum of 5 years of experience in the Life Sciences industry (pharmaceutical, biotechnology or C
• ROexperience preferre
• d)Strong experience with TMF documents including creation, tracking, implementation, maintenance, a
• ndelectronic filing and
• QCExperience in the use and development of hard copy files/electronic documentation and electronic T
• MFStrong working knowledge of ICH/GCP Guidelin
• esKnowledge of clinical development phases and process
• esLine management or team lead experien

ce
DESIRED SKILLS AND EXPERIE

• NCEAbility to build relationships with clients and co-work
• ersDetail-orientated and well organi
• zedCritical thin
• kerExperience working with eTMF or other eClinical systems such CTMS, SSU, eTMFs as Veeva Vault or Wingspan IQVIA
• TMFSuperior knowledge of the CDISC TMF Reference Mo