Site File Operations Administrator - IQVIA Biotech

IQVIA Biotech is now hiring a Site File Administrator.

BASIC FUNCTIONS:

Responsible for maintaining   IQVIA Biotech database(s) and assisting with TMF Operations Department efforts to ensure the quality and regulatory compliance of Principal Investigator (PI) credentials, Essential Documents (ED) and Investigator Site Files (ISF) throughout the clinical study.  Work with both internal and external teams to ensure good communication regarding documentation processing.  Assists with maintaining documents 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:

• Updates IQVIA Biotech database(s) as documents are received by respective team members.
• Assists in saving site documents to the shared (G) drive and file using filing conventions.
• Documents study challenges and effectively communicate those to the Associate, Lead and/or Manager.
• Assists the Specialists, Leads and Managers with reports as needed.
• Copy and assemble documents as required.
• Conducts all activities according to appropriate IQVIA Biotech and/or sponsor SOPs.
• Performs other duties as required.

(NA/EU):

• Assists with development of site training matrix and tracking of training, as applicable
• Assists with the entry of Investigator names in the Clinical Trial Management System (CTMS) database.
• Support Associate with feasibility packet development e.g. UAT for eFQ.
• Assists with, tracking and filing of reportable expedited safety reports and cross reports to sites as needed.
• Supports scheduling or minuting of team/department meetings, as applicable

India:

• Undertake filing of documents into the eTMF in Investigator Site File folders.
• Perform ALCOA review of documents, as applicable
• May assist with the entry of Investigator names in the Clinical Trial Management System (CTMS) database.

KNOWLEDGE, SKILLS & ABILITIES:

• Good written and verbal communication skills.
• Positive attitude and ability to interact with all levels of staff.
• Ability to manage multiple priorities.
• Ability to use sound judgment and assess and recommend specific solutions.
• Ability to work somewhat independently, prioritize effectively and work within a matrix team environment.
• Working knowledge of Word, Excel, Outlook and Power Point.

PHYSICAL REQUIREMENTS:

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

MINIMUM RECRUITMENT STANDARDS:

• University/College Degree, preferably in the field of science
• Equivalent combination of education, training and experience

CLASSIFICATION:

• US:  This position is classified as non-exempt under the Fair Labor Standards Act

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 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

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.