Quality Manager, Integrated Site Services, (Home-based) IQVIA Biotech

IQVIA Biotech is now hiring for a Quality Manager, Integrated Site Services

BASIC FUNCTIONS:

Responsible for the quality and regulatory compliance of the Principal Investigator (PI) credentialing, Essential Documents (ED) and Investigator Site Files (ISF) process at IQVIA Biotech.  Oversee process documentation in compliance with International Congress on Harmonization-Good Clinical Practice (ICH-GCP), country regulatory requirements and procedures set forth by IQVIA Biotech, its affiliates, and its clients. Support ISS training curriculum development and implementation, consistent with IQVIA Biotech process documents.  Support, prepare ISS teams, and manage ISS representation at all client audits involving ISS functions. 

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Leads and manages the ISS related processes and activities for ensuring that the appropriate processes and quality metrics are established in accordance with regulatory requirements and CRO/client industry standards.
• Develops, writes, reviews and provides ISS inter department audit related documentation, including Policies, SOPs, WPs, Project Master Plans.  Reviews and ensures that ISS staff are following practices, processes, and procedures are in keeping with industry quality standards and compliance requirements, including IQVIA Biotech best practices.
• Develops and implements, programs and planning for routine ISS inter department audit and liaise with QA department for client- audit preparedness. 
• Prepares audit plans, conducts audits, and writes audit findings for ISS management approval.  Ensures that finding are documented for each employee and, if needed, work with management on a plan to retrain staff on IQVIA Biotech SOPs and WPs.
• Reviews and provides feedback on ISS compliance with GCP and IQVIA Biotech’s standard operating procedures. Communicate directly with ISS staff or their manager or other study team members as appropriate to ensure TMF files are maintained in an audit ready condition at all times.
• Provide the project team with quality information, guidance, training, and support based on applicable ISS WP/SOPs, and best practices. 
• Performs other duties as assigned to maintain and track quality in the ISS organization.

KNOWLEDGE, SKILLS & ABILITIES:

• Demonstrated ability in the leadership of a team of individuals in the ISS type process activities.
• Knowledge of clinical research process and medical terminology.
• 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.
• Strong presentation skills to support client facing meetings
• Ability to manage multiple competing priorities within various clinical trials.
• Expert knowledge of current ICH GCP guidelines and applicable regulations.
• Ability to reason independently, assess and recommend specific solutions in clinical settings, and mentor ISS staff.
• Ability to work independently, prioritize and work with a matrix team environment is essential. 
• Working knowledge of Word, Excel is required. 

CRITICALJOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

• Ability to travel
• Very limited physical effort required to perform normal job duties

MINIMUM RECRUITMENT STANDARDS:

• BS/BA/BSc (or equivalent) and 6 years related experience within a clinical research environment
• Experience with electronic TMF and TMF reference model is required, preferably Wingspan TMF
• Equivalent combination of education, training and experience

CLASSIFICATION:

This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.

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.