Lead Site File Specialist
Stevenage, UK
5d ago

Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients.

Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

  • Provide oversight for Global Site File activity (from initiation to close out). Responsible for site, client and internal team communication;
  • mentoring and providing study specific training's; distribution of amendments, safety reports and ICF reviews, as applicable per region.

    Ensuring that document process is in compliance with International Congress on Harmonization-Good Clinical Practices (ICH-

    GCP), country regulatory requirements and procedures set forth by IQVIA Biotech and its clients.

  • Oversees efforts of site file maintenance and study close out with team members for a designated global project(s)
  • Works with Management to discuss projected hours for the assigned project and provides updates to appropriate project team member(s).
  • Serves as core team member in interactions with the sponsor and sites.
  • Responsible for study specific training and mentor staff as needed.
  • Provide oversight and QC site level documents for the quality and regulatory compliance from maintenance through close out phase.
  • Performs analysis of Quality Metrics reports from the TMF as applicable and escalates concerns to PM / Manager.
  • Manages periodic investigator site file reviews on assigned project(s) to ensure compliance with GCPs and IQVIA Biotech’s standard operating procedures.
  • And communicates findings with MN-R.

  • Ensures the File Review Plan is finalized for each study they oversee
  • Oversees site level timelines. Documents study challenges and communicates them to the department Manager, Sr. Mgr. or Associate Dir. and Project Manager.
  • Assist in collection of the ongoing regulatory documents from sites as necessary.
  • Escalate any site file issues to management as appropriate.
  • Oversees the distribution of updated documents (e.g. 1572, FDF) to client on a monthly basis as required.
  • Ensures necessary IRB / EC documentation (i.e. IRB continuing review, Amendment approval) Site level ICF review, and tracking system updates are completed, as necessary, and as applicable to region.
  • Manages MN-R in ensuring that Investigator names are in the Clinical Trial Management System (CTMS).
  • Updates templates during maintenance phase for regulatory documents specific to local and central Institutional Review Board (IRB) / Ethics Committee (EC) submissions, as applicable per region.
  • Responsible for compiling and distribution of ongoing regulatory documents to sites, as required.
  • Supports the Associates / Specialists on local IRB / EC submissions as necessary and operates as an escalation point of contact for any site / documentation issues.
  • Identifies out of scope activities to Management, Project Manager and team and assures that such activities do not begin until the client provides authorization.
  • Assures that team members understand budgets for the studies they are working on and are accountable for maintaining project activities within documented scope and budget.
  • Oversees any additional duties as outlined in the Site Level TMF plan as applicable.
  • Serve as IQVIA Biotech liaison with Central IRBs
  • Participates in financial and / or resource forecasting
  • Attends internal, external and client audits as applicable.
  • Performs other duties as required.
  • Apply
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