Clinical Trials Document Specialist

Job Overview
Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.

Responsibilities:
•    Reviewing all documents in assigned study files to ensure they are filed appropriately and meet required quality standards. 
•    Setting up the eTMF (electronic Trial Master File) per study specifications. 
•    Archival of eTMF documents at the conclusion of a study. 
•    Subject matter expert for end-to-end eTMF process, structure and content, including providing document retrieval support during regulatory audits and inspections.
•    Running system reports to assess eTMF health, including interpretation, delivery and follow-up with stakeholders. 
•    Contributing to process improvement activities. 

Qualifications:
•    Proficient knowledge of Good Clinical Practice (GCP), Good Documentation Practice (GDP), and required clinical study documentation, or the capacity to develop this knowledge.
•    High school diploma or equivalent.
•    Minimum of 5 years of relevant experience, including 3 years of Trial Master File experience. 
•    Independent time management and ability to balance multiple priorities. 
•    Demonstrated ability to learn new software/tools rapidly.
•    Must have strong attention to detail.
•    Strong customer orientation and a proven track record in working closely with others
Preferred:
•    Associate or 4-year degree in Biological/Life Science or equivalent.

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.