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.