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, Power Point
)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
QC Experience in the use and development of hard copy files/electronic documentation and electronic T
MFStrong working knowledge of ICH/GCP Guidelin
es Knowledge 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
ers Detail-orientated and well organi
zed Critical thin
ker Experience 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

del