Lead Site File Specialist, Home-Based, IQVIA Biotech
Company: IQVIA Holdings Inc
Posted on: June 12, 2021
IQVIA Biotech is now hiring a Lead Site File Specialist.
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 trainings;
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.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
- 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
- Serves as core team member in interactions with the sponsor and
- Responsible for study specific training and mentor staff as
- Provide oversight and QC site level documents for the quality
and regulatory compliance from maintenance through close out
- 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
- Ensures the File Review Plan is finalized for each study they
- 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
- 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
- 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
- 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
- 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
- Performs other duties as required.
KNOWLEDGE, SKILLS & ABILITIES:
- Demonstrated ability to lead a team of individuals in the
document management process.
- Extensive knowledge of clinical research process and medical
terminology including the submission process
- Strong written and verbal communication skills to express
complex ideas to study personnel, internal and sponsor team
- Excellent organizational and interpersonal skills.
- Positive attitude and ability to interact with all levels of
staff to coordinate and execute study activities.
- Ability to manage multiple competing priorities within various
- Extensive knowledge of current ICH GCP guidelines and
- Demonstrated knowledge & involvement in audit preparation
- Ability to gain successful outcomes in areas of challenge
regarding the TMF & document management
- Ability to work independently, prioritize and work with a
matrix team environment is essential.
- Working knowledge of Word, Excel is required.
- Limited travel may be required
- Very limited physical effort required to perform normal job
MINIMUM RECRUITMENT STANDARDS:
- BS/BA/BSc, or equivalent level of education, plus 5 years of
regulatory document management experience
- Experience in mentoring staff and driving team collaboration is
- Equivalent combination of education, training and
- US: This position is classified as exempt under the Fair Labor
Standards Act; employees are not eligible for overtime
- Non-US: Not applicable.
At IQVIA, we believe in pushing the boundaries of human science
and data science to make the biggest impact possible - to help our
customers create a healthier world. The advanced analytics,
technology solutions and contract research services we provide to
the life sciences industry are made possible by our 70,000+
employees around the world who apply their insight, curiosity and
intellectual courage every step of the way. Learn more at
All qualified applicants will receive consideration for
employment without regard to race, color, religion, sex, sexual
orientation, gender identity, national origin, disability, status
as a protected veteran, or any other status protected by applicable
IQVIA, Inc. provides reasonable accommodations for applicants
with disabilities. Applicants who require reasonable accommodation
to submit an application for employment or otherwise participate in
the application process should contact IQVIA's Talent Acquisition
team at email@example.com to arrange for such an
Keywords: IQVIA Holdings Inc, Syracuse , Lead Site File Specialist, Home-Based, IQVIA Biotech, Other , Ithaca, New York
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