(Senior) Study Start-Up Specialist (II) - IQVIA Biotech

BASIC FUNCTIONS:

Responsible for the quality and regulatory compliance of Principal Investigator (PI) credentials, Essential Documents (ED) and Investigator Site Files (ISF) during start-up.  Work with both internal and external teams to assure good communication, regarding documentation processing.  Assure documents maintained are following International Congress on Harmonization-Good Clinical Practices (ICH-GCP), country regulatory requirements and procedures set forth by IQVIA Biotech and its clients.  A SSUS may be assigned to one or more start-up projects, and typically is able to work independently on a project with minimal supervision.  Send regulatory document packets to sites, follow up with sites on document completion, review regulatory documents for completeness, compile in a packet for second review, review of the site informed consents and negotiate through an acceptable IRB approved document, complete study level Central IRB submissions, support sites for Central/Local IRB submission, provide updates to team/Sponsor on calls and via email. Hand off sites to Site File Maintenance, once Green Light approved. Understand scope of work and help with resource forecasting in our finance system. Manage amendments issued during SSU for sites to submit and process as required. May support Bid Defenses. Where time permits, may help with site feasibility (CDAs and Feasibility questionnaires) and Site File Operations (with tracking, amendments, other tasks to support). Workload determined by study budget and ongoing communication with line manager.

KNOWLEDGE, SKILLS & ABILITIES:

• Good knowledge of clinical research process related to study start-up and medical terminology
• An understanding of Regulatory and Central/Local ethic submission processes for assigned countries
• 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
• Working knowledge of current ICH GCP guidelines and applicable regulations
• Ability to reason independently, assess and recommend specific solutions in clinical settings, and mentor junior SSU staff
• Excellent verbal and written communication skills required in local language for assigned countries.
• Ability to work independently, prioritize and work with a matrix team environment is essential.
• Working knowledge of Word and Excel is required.
• Ability to travel periodically if needed

PHYSICAL REQUIREMENTS:

• Extensive use of telephone and face-to-face communication requiring accurate perception of speech
• Extensive use of keyboard requiring repetitive motion of fingers
• Regular sitting for extended periods of time

MINIMUM RECRUITMENT STANDARDS:

• Bachelor’s degree (or equivalent), preferably in science or related field and 3 - 5 years relevant experience including 2 years of regulatory & study-start up experience
• 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.

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.