Job Description

Uploading reviewed and approved documents in eTMF via iTMF
2. Resolving queries and following up with CRAs / SSUS/ SFAs as per need
3. Responsible for maintaining and improving the compliance of eTMF filing
4. May support SFA 1&2 in some additional task as per need
Attending transition meetings for handover of sites from SSUS along with CRAs
2. Attending monthly calls with site CRAs to resolve action items (AIs) and other queries
3. Reviewing and resolving queries for site related documents sent by SSU/CRA (post GLP
approval) for assigned studies till Close Out
4. Customizing/completing & maintaining required site-specific trackers/templates
throughout the project lifecycle till Close out
cRSU APAC SFO \xe2\x80\x93 Version 1.0 Dated 02 Apr 2021
5. Conduct periodic review of site files and other applicable trackers/templates including
File Review Plan as per applicable TMF plan
6. Generate and review compliance reports (eg. TMF, IL2, AI etc.) and take necessary actions
keeping the Lead SFA and/or SFO LM involved
7. eTMF filing of documents if needed
8. Responsible for maintaining and improving overall quality (as per GCP, Country/Study
requirements and SOPs), delivery and compliance of documents sent to SFO for review
and upload for the assigned studies
9. Participates/supports in audits as needed
10. SFA 2 \xe2\x80\x93 May act as SME and can get involved in delivering trainings

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible \xe2\x80\x93 to help our customers create a healthier world. Learn more at https://jobs.iqvia.com