Lead Site File Specialist - IQVIA Biotech

Company: IQVIA Holdings Inc
Location: Bloomington
Posted on: June 7, 2021

Job Description:

Job description

IQVIA Biotech is now hiring a Lead Site File Specialist.

BASIC FUNCTIONS:

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 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.

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 members.
• 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 clinical trials.
• Extensive knowledge of current ICH GCP guidelines and applicable regulations.
• 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.

CRITICALJOB FUNCTIONS:

• Limited travel may be required
• Very limited physical effort required to perform normal job duties

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 preferred
• Equivalent combination of education, training and experience

CLASSIFICATION:

• US: This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.
• 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 jobs.iqvia.com.

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 law.

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 workday_recruiting@iqvia.com to arrange for such an accommodation.

Keywords: IQVIA Holdings Inc, Bloomington , Lead Site File Specialist - IQVIA Biotech, Other , Bloomington, Illinois