Site File Associate (eTMF)

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Roles and Responsibilities

Review site-level documentation to ensure compliance with GCP and IQVIA Biotechs standard operating procedures from maintenance through a close-out phase.
Reviews investigator study files and identifies expired documents, upcoming continuing renewal where applicable. ]
Communicates directly with Site File Specialist/Lead, or local CRAs in various countries, to obtain corrections to incomplete/incorrect/expired documents.
Tracks any action items to CRAs/sites in CTMS or alternative process as per the client requirement.
Completes Periodic Site File Reviews per the IQVIA Biotech SOPs.
Follows the appropriate IQVIA Biotech and/or sponsor SOPs during the conduct of the study. Ensures all project documentation is appropriately filed per IQVIA Biotech SOPs, or Sponsor SOPs if required.
Adheres to study timelines, document/escalate study challenges and communicates update to Site File Specialist/Lead.
Supports audits of the Investigator Site Files, as applicable
May work as a Subject Matter Expert for regionally specific information
Performs other duties as required.

Desired Candidate Profile

Bachelor's Degree Bachelors degree in clinical, life sciences, mathematical sciences, or related field, nursing qualification or allied medical degree.
Experience in the clinical research field preferred.
Experience level may vary based on customer-specific requirements.
Advanced knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements.i.e International Conference on Harmonisation - Good Clinical Practice (ICH GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.
Good Clinical system expertise.
Experience in eTMF/CRC/CTA/CRA
Requires a minimum of 2 years of relevant work experience or equivalent combination of education, training and experience.

IQVIA RDS India Pvt. Ltd.
With a presence of more than twenty years in a country that is projected to be amongst the top three pharmaceutical markets in 2021 by YOY growth, IQVIA India takes pride in its contribution to the growth of the Indian Lifesciences industry. In parallel with the growth and development of the Indian healthcare industry, our clinical and commercial services have grown and expanded to encompass a wide portfolio today. We are committed to offering innovative business models tailored to suit the local and global aspirations of our customers in a dynamic healthcare landscape. We draw on the strength and depth of our global resources, deep domain expertise and local insights to help biotech, medical device and pharmaceutical companies, medical researchers, not for profit and government agencies, payers and other healthcare stakeholders deliver better health outcomes. Our 13,000+ employees in India are drawn from backgrounds in life sciences, healthcare analytics, information technology and consulting that help us deliver services across clinical research, data management, lifecycle safety, medical writing, biostatistics, centralized monitoring, sales and marketing, primary intelligence, real-world insights and commercial services.