Systems Analyst Team Leader (Permanent)

The Lead eClinical Systems Analyst is a senior line management role. 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). clients with trial management as required by our clients. 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.

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: 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
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
Superior communication skills in English (verbal and written)
Ability to effectively multitask in order to simultaneously execute multiple projects
Superior proficiency in Microsoft Office (Word Excel Outlook PowerPoint)

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
Knowledge of clinical development phases and processes
Line management or team lead experience

DESIRED SKILLS AND EXPERIENCE

Experience working with eTMF or other eClinical systems such CTMS SSU eTMFs as Veeva Vault or Wingspan IQVIA TMF Project Management Full-time Permanent Required Experience: